Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005334138

FEI Number

3005334138

Entity Name

St. Jude Medical, Cardiology Division, Inc.

City/State/Country

Plymouth, MN, US

Establishment Address

5050 Nathan Lane North, Plymouth, MN 55442, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K894343

PMA Number

N/A

All Registered Proprietary Names

Merlin Patient Care System Software Model 3330 Version 18.1.1 Regency family of pacemakers REPOSITIONING SLEEVE EnSite X EP System, Software Upgrade Ultimum Ultimum Introducer RadiStop HydroSteer Ampere Generator FlexAbility Ablation Catheter Sensor Enabled Ablation Connection Cable Therapy Cool Flex Ablation Catheter FlexAbility Ablation Catheter, Sensor Enabled Therapy Cool Path Duo Ablation Catheter Safire BLU Duo Ablation Catheter IBI 1500T9-CP V1.6 Cardiac Ablation Generator Ampere Generator Accessories Ampere Generator Fiber Cord Assembly Remote Ampere Generator Kit Ampere Remote Control Ampere Footswitch WorkMate Claris System EP-4 Cardiac Stimulator EP-4 Cardiac Stimulator, Keyboard EP-4 Cardiac Stimulator, Cardiac Stimulator EP-4 Cardiac Stimulator, Cardiac Stimulator Cable EP-4 Cardiac Stimulator, Touch Screen Computer Fast-Cath Transseptal Guiding Introducer Swartz Braided Transseptal Guiding Introducer EnSite X EP System Dual Monitor Mount, ENSITE-DMMK-01 EnSite X EP System Amplifier, ENSITE-AMP-01 Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-F15 EnSite X EP System Single Monitor Mount, ENSITE-SMMK-01 EnSite X EP System ECG Cable, ENSITE-CECG-144-01 EnSite X EP System IC Output Cable, ENSITE-WM56-60-01 EnSite Fixed Field Frame Bracket, ENSITE-FF-BRCKT-01 EnSite X EP System Amplifier Power Module, ENSITE-AMP-EPM-01 EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-01 EnSite X EP System Patient Reference Sensor, ENSITE-PRSFRNT-01 EnSite X EP System Connect Cable, ENSITE-ACBL-60-01 EnSite X EP System IC Output Cable, ENSITE-WM64-144-01 EnSite X EP System Amplifier, ENSITE-AMP-02 EnSite X EP System Field Frame Cable, ENSITE-FF-4.5C-01 EnSite X EP System Patient Reference Sensor, ENSITE-PRSBACK-01 EnSite X EP System IC Output Cable, ENSITE-WM64-60-01 Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-F20 EnSite X EP System Surface Electrode Kit, ENSITE-SEK-5-01 EnSite X EP System Amplifier Cart, ENSITE-AMPCART1-01 Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-V1525 Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF20-V1525 EnSite X EP System Recording System IC Output Cable, ENSITE-CR-56-01 EnSite X EP System ECG Cable, ENSITE-CECG-60-01 EnSite X EP System Catheter Input Module, ENSITE-CIM-20-01 EnSite X EP System Recording System IC Output Cable, ENSITE-CR-64-01 EnSite X EP System Remote Monitor Stand, ENSITE-RMS-01 EnSite X EP System Amplifier, ENSITE-R-AMP-02 EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-01 Advisor HD Grid High Density Mapping Catheter, Sensor Enabled, D-AVHD-DF16 EnSite X EP System Monitor Pole, ENSITE-MONPOLE-01 EnSite X EP System Catheter Input Module, ENSITE-CIM-80-01 EnSite Adjustable Field Frame Bracket, ENSITE-FF-ABRKT-01 EnSite X EP System Field Frame Cable, ENSITE-FF-3MC-01 Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-F15 EnSite X EP System Contact Force Software License, ENSITE-CF-01 EnSite X EP System Display Workstation, ENSITE-DWS-01 EnSite X EP System Amplifier Cart, ENSITE-AMPCART3-01 Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D20-V1525 EnSite X EP System ECG Output Module, ENSITE-ECGOUT-01 EnSite X EP System Connect Cable, ENSITE-ACBL-160-01 Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-V1525 EnSite X EP System Display Workstation, ENSITE-R-DWS-01 EnSite X EP System Contact Force Software License, ENSITE-D-CF-01 EnSite X EP System Amplifier, ENSITE-R-AMP-01 EnSite X EP System Triple Monitor Mount, ENSITE-TMMK-01 Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-F20 EnSite X EP System Field Frame, ENSITE-FF-01 EnSite X EP System Bedrail Mount, ENSITE-RAILMNT-01 EnSite X EP System IC Output Cable, ENSITE-WM56-144-01 EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-01 EnSite X EP System Display Workstation Cart, ENSITE-DWSCART-01 EnSite X EP System Field Frame, ENSITE-R-FF-01 EnSite Velocity System v.4 EnSite Velocity System Version 4 EnSite Precision Mapping Module Agilis NxT Steerable Introducer PressureWire X Engage TR Introducer Inquiry Inquiry Luma-Cath Agilis NxT Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer Agilis NxT Steerable Introducer Ampere RF Ablation Generator Ampere Generator Therapy Ablation Catheter Ampere Generator Fiber Cord Assembly Remote Grounding Cable 1710 Electrophysiology Cable Ampere Generator Kit Ampere Remote Control Ensite Velocity System GenConnect (GenConnect interface to Stockert generator.) Ensite Precision Field Fram Bracket Ensite Velocity DWS HDD Ensite Precision Software Installation v.2.2 30 Day Trial Ensite Precision Bedrail Mount Kit TactiCath Ablation Catheter, Sensor Enabled Software Installation 30 Day Trial Ensite Velocity Software Upgrade Kit, v5.1 Printer Ensite System GenConnect (GenConnect Interface to EPT generator.) RFB Ensite Velocity System Equipotential Cable Ensite Precision Software Installation Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) Ensite Velocity System CathLink Module Ensite Courier Software Installation v.3 Ensite Velocity RecordConnect For Use With WorkMate Claris System Ensite Fusion Software Upgrade Kit v.7.1 Ensite Precision Field Frame Storage Bracket Ensite Courier Software Installation v.3 30 Day Trial Ensite Display Workstation Ensite Velocity Amplifier Cart Ensite Precision Patient Reference Sensor Ensite Verismo Software Upgrade Kit v.2.1 Ensite Velocity Display Workstation (DWS) AutoMark Software Installation v.1 Ensite System RecordConnect RFB Ensite Velocity System EP-WorkMate RecordConnect Ensite Velocity System Remote Monitor Stand Ensite Velocity ArrayLink Module GenConnect Ensite Velocity System Workstation Cart Ensite Velocity System GenConnect (GenConnect interface to Stockert SmartAblate generator.) Ensite Velocity System DWS Kit Ensite Velocity Amplifier and Display Workstation Ensite Velocity CathLink Module Ensite Contact Force Module Software Installation v.2 30 Day License Ensite Velocity Sytstem Workstation Ensite Velocity System Workstation Accessory Kit Ensite Velocity System Amplifier Kit Ensite System GenConnect (GenConnect Interface to EPT generator.) Ensite Velocity System Cable Accessory Kit Record Connect Ensite Velocity System Monitor 24" Ensite Precision Field Frame Cable Ensite Velocity Software Upgrade Kit, v5.2.1 Ensite Velocity Display Workstation DWS Kit Ensite Velocity Kit, GenConnect, Stockert, NST Ensite Velocity Display Workstation Ensite Velocity NavLink Module Ensite Velocity System Amplifier Cart Ensite Velocity Amplifier Ensite Velocity System GenConnect Ensite Derexi Module v.1.3.1 Ensite Precision Link, Sensor Enabled Link AutoMark Installation Kit Ensite Precision Software Installation v.2.1 TactiCath Ablation Catheter, Sensor Enabled Catheter Catalog Installation, v.1 Ensite Velocity RecordConnect Ensite Velocity Cable Assembly Kit, T Series Ensite Velocity System RecordConnect Kit Universal Ensite Velocity System GE CardioLab RecordConnect Ensite Amplifier and Display Workstation Ensite Precision Field Frame Bracket Ensite Velcity System GenConnect (GenConnect interface to Stockert generator.) Ensite AutoMap Module v.1 30 Day Trial Ensite Contact Force Module Software Installation Remote Monitor Stand Power Cord, Compatible with St. Jude Medical Electrophysiology Products Ensite Velocity System GenConnect (GenConnect interface to T-series generator.) Ensite Velocity Bard Clearsign RecordConnect Ensite Velocity Software Upgrade Kit, v5.2 Ensite Contact Force Module Software Installation, v.2 Ensite Velcity System Display Workstation Kit Ensite Velocity Workstation Cart Ensite Velocity System Workstation Ensite Precision Field Frame Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled Ensite System RecordConnect TactiCath Ablation Catheter, Sensor Enabled Software Installation Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation Ensite Velocity System RecordConnect Ensite Velocity EP-WorkMate Record Connect Ensite Precision Software Installation v.2.2 Ensite Velocity System Siemens RecordConnect Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) RFB Ensite MediGuide Interface Module Software Installation v.1.1 Ensite Velocity Amplifier and DWS Ensite System GenConnect (GenConnect interface to Atakr generator.) RFB Ensite Precision Software Installation v.2.1 30 Day Trial Ensite Velocity System GenConnect Kit IBI Ensite Velocity Remote Monitor Stand FlexAbility Ablation Catheter, Sensor Enabled Software Installation Ensite Velocity System RecordConnect (RecordConnect interface to Bard Clearsign recording system.) Ensite Contact Force Module Installation Kit Ensite Precision Module, Sensor Enabled Module Ensite Precision Software Installation v.2 30 Day Trial Advisor FL Mapping Catheter, Sensor Enabled Software Installation Ensite System GenConnect (GenConnect interface to Atakr generator.) Ensite Precision Power Supply Kit Ensite AutoMap Module v.1 Engage Introducer Engage TR Introducer MediGuide Enabled Livewire Steerable EP Catheter Ensite Velocity Cardiac Mapping System V.2, Ensite Precision Cardiac Mapping System V2.2 Disposable RF Electrode (RFDE-5, RFDE-10, RFDE-15, RFDE-20) Advisor VL Circular Mapping Catheter, Sensor Enabled Sensor Enabled Diagnostic Connection Cable Reflexion Spiral EP Extension Adaptor EnSite X EP System Catheter Connector Cable, D-ENS-AVSE-5-CBL EnSite X EP System Catheter Connector Cable, D-ENS-SUP-D-CBL Response Electrophysiology Extension Cable Supreme Electrophysiology Cable EnSite X EP System Catheter Connector Cable, D-ENS-INQ-OD-CBL EnSite X EP System Catheter Connector Cable, D-ENS-AVSE-6-CBL Electrophysiology Extension Cable EnSite X EP System Catheter Connector Cable, D-ENS-L/R-HOD-CBL EnSite X EP System Catheter Connector Cable, D-ENS-INQ-Q-CBL EnSite X EP System Catheter Connector Cable, D-ENS-SUP-Q-CBL EnSite X EP System Catheter Connector Cable, D-ENS-SUP-DDY-CBL EnSite X EP System Catheter Connector Cable, D-ENS-L/R-BQ-CBL EnSite X EP System Catheter Connector Cable, D-ENS-INQ-DD-CBL EnSite X EP System Catheter Connector Cable, D-ENS-SUP-H-CBL EnSite X EP System Catheter Connector Cable, D-ENS-L/R-DDY-CBL Electrophysiology Cable EnSite X EP System, Catheter Connector Cable, A-ENS-MAGEXT-CBL Sensor Enabled Cable, Diagnostic Catheter Cable EnSite X EP System Catheter Connector Cable, ICE-VFSE-2D-CBL EnSite X EP System Catheter Connector Cable, D-ENS-AVHDX-CBL Ultimum Hemostasis Introducer IBI-1100 Bi-Directional Steerable Electrophysiology Catheter System Inquiry Steerable Diagnostic Catheter TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-DD-X TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-JJ-X TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-FJ TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-D TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-J Ampere Generator Kit TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-DD TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-DF TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-FF TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-FF-X TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-F Unified Connector RF SE Cable, Radiofrequency Cable TactiSys Quartz, TactiFlex Radiofrequency Cable, TSQ-RF-TFSE-CBL TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-JJ TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-FJ-X TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-J-X Ampere Remote Control Ampere Generator TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-F-X TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-DF-X TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-D-X EP-WorkMate System Radi Analyzer Xpress Adapter 12748 PressureWire Net PW USB Receiver AO USB Receiver Wi-box Wi-Box AO Transmitter, Signal Transmitter Repositioning Sleeve PressureWire Receiver PressureWire Aeris Agile Tip PressureWire Certus Agile Tip Advisor HD Grid Sensor Enabled, High Density Mapping Catheter ViewFlex Eco, Reprocessed ICE Catheter Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer Agilis NxT, Steerable Introducer Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter ViewFlex Xtra, ICE Catheter EP-NurseMate EP-NurseMate with Physio Module IonicRF Generator EnSite NavX Surface Electrode Kit EnSite Array Multi-electrode Diagnostic Catheter EnSite Velocity System v.3 EnSite Velocity System OneModel ViewFlex Xtra ICE Catheter GuideRight Guidewires Fast-Cath Transseptal Guiding Introducer Ensite Velocity Software Upgrade Kit, v5.2.1 Ensite Velocity System Siemens RecordConnect Ensite Precision Software Installation v.2.1 Ensite Precision Power Supply Kit Ensite Velcity System Display Workstation Kit Ensite Velocity System Amplifier Kit Remote Monitor Stand Ensite Precision Field Frame Cable, Ensite Velocity Amplifier and Display Workstation Ensite Velocity Kit, GenConnect, Stockert, NST TactiCath Ablation Catheter, Sensor Enabled Software Installation Ensite Amplifier and Display Workstation, EE3000 TactiCath Ablation Catheter, Sensor Enabled Catheter Catalog Installation, v.1 GenConnect Ensite Precision Software Installation v.2.1 30 Day Trial Ensite Velocity System GenConnect Kit IBI Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, H702519 Ensite Precision Field Frame Bracket, H702472 Ensite System RecordConnect RFB Ensite Velocity Remote Monitor Stand Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled, H702532 Ensite Precision Software Installation Power Cord, Compatible with St. Jude Medical Electrophysiology Products Ensite AutoMap Module v.1, H702498 Ensite Precision Patient Reference Sensor Printer Ensite Velocity System RecordConnect Kit Universal Ensite Velocity Display Workstation Ensite Velocity Software Upgrade Kit, v5.1 Ensite Velocity System CathLink Module Ensite AutoMap Module v.1 30 Day Trial, H702498-T Ensite Velocity System GenConnect (GenConnect interface to Stockert generator.) Ensite Velocity Amplifier Cart Ensite Velocity Amplifier and DWS Ensite Velocity System EP-WorkMate RecordConnect EnSite Precision Surface Electrode Kit, PRCN-SEK-A Ensite Derexi Module v.1.3.1, H702502 Ensite Velocity DWS HDD TactiCath Ablation Catheter, Sensor Enabled Software Installation 30 Day Trial Ensite Velocity Display Workstation (DWS) Ensite Velocity System Workstation EnSite Precision Surface Electrode Kit Ensite Precision Link, Sensor Enabled Link Ensite Velocity System Remote Monitor Stand AutoMark Installation Kit, H702499-HW Ensite Velocity System GenConnect (GenConnect interface to T-series generator.) Ensite System GenConnect (GenConnect interface to Atakr generator.) Ensite Velocity CathLink Module Ensite System GenConnect (GenConnect Interface to EPT generator.) Ensite Precision Software Installation v.2 30 Day Trial Ensite Precision Bedrail Mount Kit, H702474 Ensite Velocity System GenConnect (GenConnect interface to Stockert SmartAblate generator.) Ensite Precision Field Frame Storage Bracket EnSite Precision Patient Reference Sensor SURF-ELEC-2PRS Ensite System GenConnect (GenConnect interface to Atakr generator.) RFB Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) Ensite Velocity RecordConnect For Use With WorkMate Claris System EnSite Precision Module, Sensor Enabled Module Ensite Velocity RecordConnect Ensite Velocity System Equipotential Cable Ensite Velocity EP-WorkMate Record Connect Ensite Precision Field Frame, H702469 AutoMark Software Installation v.1, H702499 Ensite Velocity ArrayLink Module Ensite Precision Software Installation v.2.2 30 Day Trial Ensite Velocity System Workstation Accessory Kit Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) RFB Ensite Velocity System Cable Accessory Kit Ensite Velocity Amplifier Ensite Fusion Software Upgrade Kit v.7.1, H702506 Ensite Contact Force Module Software Installation, H702500 Record Connect Ensite Velocity Cable Assembly Kit, T Series Ensite Velocity Workstation Cart FlexAbility Ablation Catheter, Sensor Enabled Software Installation Ensite Velocity System Amplifier Cart Ensite Contact Force Module Software Installation v.2 30 Day License, H702500-T Ensite Velcity System GenConnect (GenConnect interface to Stockert generator.) EnSite System Reference Electrode, SYS-REF-V1 Ensite Precision Field Frame Bracket, H702472-E Advisor FL Mapping Catheter, Sensor Enabled Software Installation, H702507 Ensite Contact Force Module Software Installation, v.2, H702500 Ensite Velocity System RecordConnect Ensite Velocity System GE CardioLab RecordConnect Ensite Precision Software Installation v.2.2 EnSite Velocity Surface Electrode Kit Large, 5 Pack EN0010-10000331 Ensite Courier Software Installation v.3, H702501 Ensite Velocity Bard Clearsign RecordConnect Ensite Velocity System GenConnect Ensite Contact Force Module Installation Kit, H702500-HW Ensite System RecordConnect Ensite Verismo Software Upgrade Kit v.2.1 Ensite Velocity Sytstem Workstation Ensite Courier Software Installation v.3 30 Day Trial, H702501-T Ensite Velocity Software Upgrade Kit, v5.2 Ensite Velocity System Workstation Cart Ensite Velocity System RecordConnect (RecordConnect interface to Bard Clearsign recording system.) Ensite Display Workstation, EE3000 Ensite Velocity System Monitor 24" Ensite MediGuide Interface Module Software Installation v.1.1, H702503 Ensite Velocity System DWS Kit Ensite System GenConnect (GenConnect Interface to EPT generator.) RFB Ensite Velocity NavLink Module Ensite Velocity Display Workstation DWS Kit EnSite Precision Adjustable Field Frame Bracket EnSite CathLink Module, Catheter Input Module EnSite GenConnect Module, Generator Connector EnSite RecordConnect Module, Recording System Connector EnSite NavLink Module, Surface Electrode Connector EnSite ArrayLink Module, Catheter Input Module Ultimum EV Hemostasis Introducer 'PEEL-AWY INTRO KIT SMK Radiofrequency Needle Sheath Obturator Current PFA Radiolucent ECG Lead Set Current PFA ECG Trunk Cable Volt PFA Kit Current PFA Catheter Input Module Current PFA Unified Cable Current PFA Generator Cart Current PFA Recording System Connect Cable Volt PFA Catheter, Sensor Enabled Current PFA Radiopaque ECG Lead Set Current PFA Generator Current PFA Generator Software Upgrade Cables EnSite Velocity System v.4.2 EnSite Precision Mapping Module Upgrade Kit EnSite Contact Force Module Peel Away Introducer kit replacement syringe accessory Models 405104, 405108, 405112, 405116, 405118, 405119, 405120, 40 Bedrail Clamp- 100007639 EnSite Velocity Stockert GenConnect (Refurb) - 100047843 EnSite X EP System Contact Force Software License, ENSITE-D-CFLF-01 EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-I-01 Power Kit OUS-H702505 EnSite X EP System ECG Output Module, ENSITE-ECGOUT-I-01 TactiCath Ablation Catheter, Sensor Enabled, Catheter Catalog Installation, v.1 - H702518 EnSite X EP System Contact Force Software License, ENSITE-CFLF-01 EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-I-01 Recorder Interconnect Kit, Bard V5 - 75-04629-002 Ensite Velocity Intl Power Kit - 100019046 EnSite Velocity Ablation Cable Kit, Stockert - 75-04469-003 EnSite System (RFB GenConnect interface to Atakr generator) - 100039379 EnSite Velocity Ablation Cable Kit, IFI, T9 - 75-05392-001 EnSite Verismo, Software Installation, v.2.x - H00001 EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-I-01 EnSite System GenConnect (GenConnect interface to EPT generator) - 100038592 EnSite Velocity Amplifier Cart - H710002 EnSite Precision Module - Hardware- H702473 TactiCath Ablation Catheter, Sensor Enabled, Software Installation, 30 Day Trial - H702517-T EnSite X EP System TactiFlex Ablation Catheter Sensor Enabled Software Upgrade, ENSITE-TFM-01 RecordConnect (Universal Refurb) - 100040093 EnSite X EP System TactiFlex Ablation Catheter Sensor Enabled Software License, ENSITE-TF-01 WorkMate Claris System, Power Kit, China WorkMate Scribe Module ENSITE-GENECG-OUS EnSite X EP System PFA ECG Signal Splitter EnSite X EP System, PFA Index, Software License (ENSITE-PI-01) WorkMate Claris System EnSite X EP System, TactiFlex Duo Ablation Catheter, Sensor Enabled Temporary, Software License (ENSITE-D-FOCAL-01) EnSite X EP System, EnSite AI Geo Temporary Software License, ENSITE-D-AGL-01 EnSite X EP System, EnSite AI Geo Software License, ENSITE-AG-01 EnSite X EP System, PFA Index Temporary, Software License (ENSITE-D-PI-01 ) EnSite X EP System, TactiFlex Duo Ablation Catheter, Sensor Enabled, Software License (ENSITE-FOCAL-01) TigerWire GuideWires EnSite X EP System Display Workstation, ENSITE-R-DWS-01 EnSite X EP System IC Output Cable, ENSITE-WM64-60-01 EnSite X EP System Bedrail Mount, ENSITE-RAILMNT-01 EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-01 EnSite X EP System Patient Reference Sensor, ENSITE-PRSFRNT-01 EnSite X EP System Monitor Pole, ENSITE-MONPOLE-01 EnSite X EP System Field Frame, ENSITE-R-FF-01 EnSite X EP System Amplifier Power Module, ENSITE-AMP-EPM-01 EnSite X EP System IC Output Cable, ENSITE-WM64-144-01 EnSite X EP System EnSite Omnipolar Technology Data Export, ENSITE-OTEXPORT-01 EnSite X EP System IC Output Cable, ENSITE-WM56-144-01 EnSite X EP System Connect Cable, ENSITE-ACBL-60-01 EnSite X EP System Display Workstation, ENSITE-DWS-1.1 EnSite X EP System ECG Cable, ENSITE-CECG-144-01 EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-01 EnSite X EP System Software Upgrade, ENSITE-SW-1.1.2 EnSite X EP System Patient Reference Sensor, ENSITE-PRSBACK-01 EnSite X EP System Contact Force Software License, ENSITE-CF-01 EnSite Fixed Field Frame Bracket, ENSITE-FF-BRCKT-01 EnSite X EP System Triple Monitor Mount, ENSITE-TMMK-01 EnSite X EP System EnSite LiveView Dynamic Display Demo, ENSITE-D-LV-01 EnSite X EP System Wave Speed Map, ENSITE-WS-01 EnSite X EP System EnSite LiveView Dynamic Display, ENSITE-LV-01 EnSite X EP System IC Output Cable, ENSITE-WM56-60-01 EnSite X EP System Amplifier Cart, ENSITE-AMPCART3-01 EnSite X EP System Single Monitor Mount, ENSITE-SMMK-01 EnSite X EP System Catheter Input Module, ENSITE-CIM-80-01 EnSite X EP System Recording System IC Output Cable, ENSITE-CR-56-01 EnSite X EP System EnSite Omnipolar Technology, ENSITE-OT-01 EnSite X EP System ECG Cable, ENSITE-CECG-60-01 EnSite X EP System Amplifier Cart, ENSITE-AMPCART1-01 EnSite X EP System Amplifier, ENSITE-R-AMP-01 EnSite X EP System ECG Output Module, ENSITE-ECGOUT-01 EnSite X EP System Software Upgrade, ENSITE-SW-1.1 EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-01 EnSite X EP System Display Workstation, ENSITE-DWS-01 EnSite X EP System Field Frame, ENSITE-FF-01 EnSite X EP System Catheter Input Module, ENSITE-CIM-20-01 EnSite X EP System Connect Cable, ENSITE-ACBL-160-01 EnSite X EP System Field Frame Cable, ENSITE-FF-4.5C-01 EnSite X EP System Amplifier, ENSITE-R-AMP-02 EnSite X EP System Contact Force Software License, ENSITE-D-CF-01 EnSite X EP System Dual Monitor Mount, ENSITE-DMMK-01 EnSite X EP System Live Export Software License, ENSITE-LE-01 EnSite X EP System Amplifier, ENSITE-AMP-02 EnSite X EP System Amplifier, ENSITE-AMP-01 EnSite X EP System Remote Monitor Stand, ENSITE-RMS-01 EnSite X EP System Surface Electrode Kit, ENSITE-SEK-5-01 EnSite Adjustable Field Frame Bracket, ENSITE-FF-ABRKT-01 EnSite X EP System Recording System IC Output Cable, ENSITE-CR-64-01 EnSite X EP System Software Upgrade, ENSITE-SW-1.1.1 EnSite X EP System EnSite Omnipolar Technology Demo, ENSITE-D-OT-01 EnSite X EP System Field Frame Cable, ENSITE-FF-3MC-01 EnSite X EP System Wave Speed Map Demo, ENSITE-D-WS-01 EnSite X EP System Display Workstation Cart, ENSITE-DWSCART-01 EnSite X EP System Display Workstation, ENSITE-R-DWS-1.1 Reflexion Spiral Variable Radius Ca Inquiry Advisor HD Grid Mapping Catheter, Sensor Enabled PressureWire Aeris / Certus (Gen 8) CPS Direct SL Outer Catheter-410190 Response with Lumen Classic Radiofrequency Cannula Advisor HD Grid X, Sensor Enabled High Density Mapping Catheter Advisor HD Grid X Mapping Catheter, Sensor Enabled ViewFlex Xtra ICE Catheter ViewFlex X ICE Catheter, Sensor Enabled Maximum Hemostasis Introducer Contamination Cover/Protective Cap Ultimum Maximum Engage Introducer Engage TR Introducer Ensite Velocity Cardiac Mapping System V.2, Ensite Precision Cardiac Mapping System V2.2 Fast-Cath Guiding Introducer Fast-Cath Transseptal Guiding Introducer FastCath Hemostasis Introducer EnSite X EP System, AutoMark Index Temporary, Software License, ENSITE-D-AMI-01 EnSite X EP System, AutoMark Index, Software License, ENSITE-AMI-01 Safire Bi-Directional Catheter Ampere Generator Livewire TC Ablation Catheter Ampere Generator Kit Ampere Generator Fiber Cord Assembly Remote Safire Catheter Extension Cable Ampere Remote Control Fast-Cath Guiding Introducer Fast-Cath Transseptal Guiding Introducer Fast-Cath Hemostasis Introducer Fast-Cath Trio Hemostasis Introducer Fast-Cath Duo Hemostasis Introducer GuiderRight Guidewires EnSite LiveView Dynamic Display Software License EnSite Precision Software Installation v2.6 EnSite Precision Software Upgrade v2.7.1 EnSite Precision Software Installation v.2.7 H702701 EnSite Precision Surface Electrode Kit EN0020-p EnSite Precision System Software Upgrade v.2.6.1, H702602 ENSITE-R-SYS-04 EnSite X EP System ENSITE-SYSTEM-04 EnSite X EP System ENSITE-D-ADASLA-01 ADAS 3D LA License Temporary Software License ENSITE-ADASLV-01 ADAS 3D LV License Software License ENSITE-CECG-60-01 EnSite X EP System ECG Cable ENSITE-OTAC-02 EnSite X EP System OTA Certificate Software License ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module ENSITE-SW-1.1 EnSite X EP System Software Upgrade ENSITE-IMP-01 EnSite X EP System, Averaged Impedance Drop, Software License ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade ENSITE-SW-03 EnSite X EP System Software Upgrade ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole ENSITE-SW-3.1 EnSite X EP System, Software Upgrade ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket ENSITE-ACBL-60-01 EnSite X EP System Connect Cable ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount ENSITE-TFM-03 EnSite X EP System, TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade ENSITE-R-AMP-01 EnSite X EP System Amplifier ENSITE-TFM-3.1 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade ENSITE-AMD-01 EnSite X EP System, AutoMark Distance, Software License ENSITE-WM64-60-01 EnSite X EP System IC Output Cable ENSITE-DWS-3.1 EnSite X EP System, Display Workstation ENSITE-CF-01 EnSite X EP System Contact Force Software License ENSITE-FF-01 EnSite X EP System Field Frame ENSITE-SYSTEM-3.1 EnSite X EP System ENSITE-AAF-01 EnSite X Amplifier Air Filter ENSITE-SW-1.1.2 EnSite X EP System, Software Upgrade ENSITE-R-FF-01 EnSite X EP System Field Frame ENSITE-FWV-02 EnSite X EP System, EnSite PFA Catheter Visualization Software License ENSITE-D-LS-01 EnSite X EP System, LiveSync Demo, Software License ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License ENSITE-SYSTEM-201 EnSite X EP System ENSITE-ACBL-160-01 EnSite X EP System Connect Cable ENSITE-DWS-1.1 EnSite X EP System Display Workstation ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License ENSITE-GENECG-NAM EnSite X EP System PFA ECG Signal Splitter ENSITE-WM64-144-01 EnSite X EP System IC Output Cable ENSITE-HDGX-01 EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License ENSITE-D-AMD-01 EnSite X EP System, AutoMark Distance Demo, Software License ENSITE-D-ADASLV-01 ADAS 3D LV License Temporary Software License ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit ENSITE-SW-2 EnSite X EP System Software Upgrade ENSITE-CECG-144-01 EnSite X EP System ECG Cable ENSITE-D-IMP-01 EnSite X EP System, Averaged Impedance Drop Demo, Software License ENSITE-DWS-2.1 EnSite X EP System Display Workstation ENSITE-R-DWS-3.1 EnSite X EP System, Display Workstation ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module ENSITE-R-SYS-3.1 EnSite X EP System ENSITE-D-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License ENSITE-R-DWS-04 EnSite X EP System Display Workstation ENSITE-SW-3.2 EnSite X EP System Software Upgrade v3.2 ENSITE-WM56-144-01 EnSite X EP System IC Output Cable ENSITE-D-FWV-02 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License ENSITE-ADAS-01 ADAS 3D Base License Software License ENSITE-AMP-02 EnSite X EP System Amplifier ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation ENSITE-D-FLEX-01 EnSite X EP System, VoXel Flex Demo, Software License ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License ENSITE-D-FWV-01 EnSite X EP System, EnSite PFA Catheter Visualization Temporary, Software License ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable ENSITE-SW-3.1.1 EnSite X EP System Software Upgrade ENSITE-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Software License ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable ENSITE-TFM-3.2 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade ENSITE-FLEX-01 EnSite X EP System, VoXel Flex, Software License ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License ENSITE-R-DWS-01 EnSite X EP System Display Workstation ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable ENSITE-ECGRL-01 EnSite X EP System, Radio-lucent ECG Lead Set ENSITE-LE-01 EnSite X EP System Live Export Software License ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount ENSITE-DWS-01 EnSite X EP System Display Workstation ENSITE-AMP-01 EnSite X EP System Amplifier ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License ENSITE-R-AMP-02 EnSite X EP System Amplifier ENSITE-SW-2.1 EnSite X EP System Software Upgrade ENSITE-FWV-01 EnSite X EP System EnSite PFA Catheter Visualization, Software License ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License ENSITE-SW-1.2 EnSite X EP System Software Upgrade ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor ENSITE-LS-01 EnSite X EP System, LiveSync, Software License ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart ENSITE-SYSTEM-111 EnSite X EP System ENSITE-WM56-60-01 EnSite X EP System IC Output Cable ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License ENSITE-D-CF-01 EnSite X EP System Contact Force Software License ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License ENSITE-OTAC-03 EnSite X EP System OTA Certificate Software License ENSITE-PFAGEN-01 EnSite X EP System PFA Generator Connect Cable ENSITE-ADASLA-01 ADAS 3D LA License Software License ENSITE-DWS-04 EnSite X EP System Display Workstation BRK XS Series Transseptal Needle G407211 BRK XS Series Transseptal Needle G407208 BRK-1 XS Series Transseptal Needle G407209 BRK-1 Transseptal Needle 407201 BRK XS Series Transseptal Needle G407210 BRK Transseptal Needle 407205 BRK-1 XS Series Transseptal Needle G407212 BRK-1 XS Series Transseptal Needle G407216 BRK Transseptal Needle 407206 BRK Transseptal Needle 407200 BRK-1 Transseptal Needle 407207 BRK Transseptal Needle G407215 PressureWire X TactiSys Quartz Equipment TactiCath Contact Force Ablation Catheter, Sensor Enabled Ampere Generator Ampere Remote Control Ampere Generator Kit Ampere Generator Fiber Cord Assembly Remote ViewFlex Eco Reprocessed ICE Catheter D087031-R Inquiry AFocus II Diagnostic Catheter EnSite Velocity System EE3000 Livewire Steerable Electrophysiology Catheter WorkMate Claris System, Cable Kit WorkMate Claris System, ECG Cable Set, Radiopaque Radiotranslucent Leadwire Kit ECG Cable Radio-Translucent 36in Brn Mouse, PS2, Wired WM Claris Additional Monitor Cable Kit Cable Assy, Stim, EP4 Catheter Input Module 1-56 Cable Assy, IBP, Baxter Truwave Cable Assy, IBP, Merit Meritrans v.1.2.1 Onyx Scribe Upgrade Kit Fiber Optic Cable - Duplex LC/LC Power Supply Connector Adapter WorkMate ImageSync Module WM Claris CPU Ferrite, Round Cable Snap-its, 200MHz-10 Kit WM Claris V1.1 Upgrade WM Claris Z440 v.1.2 Upgrade Kit Cable Assy, IBP, Namic Preceptors DT WM Scribe Onyx v.1.2 Upgrade Kit Media Conv, DB9 to Fiber SC Cable Assy, IBP, Abbott Transpac IV Cable Assy, IBP, Maxxim Cobe SCU II Assembly 448 Channel EP-4 Stimulator System 110V USB Optical Scroll Mouse, Wired v.1.2.1 Z440 Upgrade Kit S-Video to VGA Signal Converter Power Conditioner, 120 VAC, 1440 VA Medi Cable Assy, IBP, Medex 960 SCU II Assembly 96 Channel DVI to HDMI Adapter LCD Dual Monitor Mount Kit Reverse IEC Accessory Power Strip WM Unity Review Module - 10 User License Monitor, Touch Screen LCD, 19 Inch Media Conv, SC Fiber to DB9 Cable Assy, IBP, Omedha DTXX EP-WorkMate/EP-4 USB Keyboard WorkMate Scribe Module 110V with Physio USB Keyboard, Wired, English DVI to DisplayPort Adapter WM Claris Power Kit, 110 Power Conditioner, 120 VAC, 600 VA, Cable Assy, IBP, Medex 860 WorkMate Claris System, Bed Rail Kit Keyboard, PS2, Wired 2-port DVI splitter Cable Equipotential v.1.2.1 Z620 Upgrade Kit WorkMate Claris System, System - Display Plus WorkMate Claris System, Generic Stimulator Cable WorkMate Scribe CPU Ferrite round cable snap its 1 to 300MHz WM Unity Review Mod - Sgl User License WorkMate Scribe Module Monitor, LCD, 16:9 1920x1080 Resolution WorkMate Unity DICOM Module 4 Outlet Reverse IEC Accessory Power Str Cable Assy, IBP, Utah Deltran WM Claris Z620 v.1.2 Upgrade Kit Cable Assy, IBP, Medex 950 WorkMate Claris System Display Workstation EP-4 Cardiac Stimulator, Cardiac Stimulator Cable incorrect Power Cord, C-18 to C-7, 250V Stim Cable, WorkMate Claris Generic EP-4 Touch Screen Computer Additional Monitor Stand Kit WorkMate Claris System, Amplifier WorkMate Claris PM Kit DWG 90169898 WorkMate Claris System, ECG Cable Set, Radiolucent EP-4 Cardiac Stimulator WorkMate Claris System, CI Module 2 WorkMate Scribe Module, Software Upgrade Kit WorkMate Claris System, Bottom Shelf Computer Bench WorkMate Claris System, Module Cart WorkMate Unity HL7 Module Catheter Input Module 57-120 WM Unity Review Module - Site License WorkMate Claris System, Cart Fiber Optic Cable - Duplex LC/LC 30m Cable, Serial, 3 ft DB9 Power Supply, 5V MG with 2.5MM I.D. DMS59 to Dual DVI SPlitter Video Cable Cable, COAX WorkMate Claris OS Patch SW Kit WorkMate Claris Bed Rail Kit WorkMate Claris System, Software Upgrade Kit WorkMate Claris System, Bed Bracket Assembly WorkMate Claris System, Display Plus Amplifier WorkMate Claris System, Preventative Maintenance Kit WorkMate Claris System, Invasive Blood Pressure Cable WorkMate Claris System, Printer WorkMate Claris System, Grounding Cable WorkMate Claris System, CI Module 1 WorkMate Claris System WorkMate Claris System, Bracket Bottom Shelf Computer Bench WorkMate Claris System, ECG Cable WorkMate Scribe Module, Display Workstation Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer Agilis NxT, Steerable Introducer ViewFlex Eco Reprocessed ICE catheter Seal-Away Introducer Peel-Away Introducer VantageView Fast-Cath Guiding Introducer Telesheath Guiding Introducer Advisor FL Circular Mapping Catheter, Sensor Enabled Peel-Awy Agilis NxT Introducer Fast-Cath Trio Hemostasis Introducer PFA-GEN-OVERLAY-F Current PFA Overlay A-VOLT-01 Volt PFA Catheter, Sensor Enabled PFA-TSQ-CBL Current PFA TactiSys Connect Cable TactiFlex Duo Sensor Enabled Ablation Catheter PFA-AMP-RETURN-CBL Current PFA Ampere Return Electrode Cable PFA-GEN-OVERLAY Current PFA Overlay PFA-GEN-V110 Current PFA Generator Software Upgrade WorkMate Claris System Inquiry Inquiry Optima PLUS Inquiry Optima Inquiry Afocus Inquiry AFocus II SJM Vessel Dilator CardioMEMS HF System CardioMEMS Hospital Electronics System CardioMEMS Patient Electronics System Merlin.net Patient Care Network Heart Failure Portal CardioMEMS PA Sensor and Delivery System CardioMEMS Hospital System CardioMEMS HERO Device ViewFlex Eco Reprocessed ICE Catheter D087031-R ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License ENSITE-FLEX-01 EnSite X EP System, VoXel Flex, Software License ENSITE-DWS-01 EnSite X EP System Display Workstation ENSITE-D-CF-01 EnSite X EP System Contact Force Software License ENSITE-SW-2.1 EnSite X EP System Software Upgrade ENSITE-D-AMD-01 EnSite X EP System, AutoMark Distance Demo, Software License ENSITE-DWS-1.1 EnSite X EP System Display Workstation ENSITE-LS-01 EnSite X EP System, LiveSync, Software License ENSITE-D-IMP-01 EnSite X EP System, Averaged Impedance Drop Demo, Software License ENSITE-IMP-01 EnSite X EP System, Averaged Impedance Drop, Software License ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License ENSITE-AAF-01 EnSite X Amplifier Air Filter ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module ENSITE-R-AMP-02 EnSite X EP System Amplifier ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module ENSITE-DWS-2.1 EnSite X EP System Display Workstation ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License ENSITE-ACBL-60-01 EnSite X EP System Connect Cable ENSITE-SW-1.2 EnSite X EP System Software Upgrade ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable ENSITE-WM64-144-01 EnSite X EP System IC Output Cable ENSITE-WM64-60-01 EnSite X EP System IC Output Cable ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount ENSITE-FF-01 EnSite X EP System Field Frame ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade ENSITE-FWV-01 EnSite X EP System EnSite PFA Catheter Visualization, Software License ENSITE-AMP-02 EnSite X EP System Amplifier ENSITE-SW-3.2 EnSite X EP System Software Upgrade v3.2 ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable ENSITE-SYSTEM-111 EnSite X EP System ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set ENSITE-CF-01 EnSite X EP System Contact Force Software License ENSITE-SW-1.1 EnSite X EP System Software Upgrade ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand ENSITE-ECGRL-01 EnSite X EP System Radio-lucent ECG Lead set ENSITE-D-LS-01 EnSite X EP System, LiveSync Demo, Software License ENSITE-AMD-01 EnSite X EP System, AutoMark Distance, Software License ENSITE-ACBL-160-01 EnSite X EP System Connect Cable ENSITE-AMP-01 EnSite X EP System Amplifier ENSITE-LE-01 EnSite X EP System Live Export Software License ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License ENSITE-CECG-60-01 EnSite X EP System ECG Cable ENSITE-SYSTEM-201 EnSite X EP System ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation ENSITE-SW-2 EnSite X EP System Software Upgrade ENSITE-SW-1.1.2 EnSite X EP System, Software Upgrade ENSITE-R-FF-01 EnSite X EP System Field Frame ENSITE-WM56-144-01 EnSite X EP System IC Output Cable ENSITE-D-FLEX-01 EnSite X EP System, VoXel Flex Demo, Software License ENSITE-CECG-144-01 EnSite X EP System ECG Cable ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor ENSITE-TFM-3.2 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit ENSITE-R-DWS-01 EnSite X EP System Display Workstation ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor ENSITE-TFM-03 EnSite X EP System, TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable ENSITE-R-AMP-01 EnSite X EP System Amplifier ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module ENSITE-SW-03 EnSite X EP System Software Upgrade ENSITE-WM56-60-01 EnSite X EP System IC Output Cable ENSITE-ECGRL-01 EnSite X EP System, Radio-lucent ECG Lead Set ENSITE-D-FWV-01 EnSite X EP System, EnSite PFA Catheter Visualization Temporary, Software License ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart Procure Endomyocardial Biopsy Forceps Percutaneous Catheter Introducer & Removable Hemo Hemostasis Valve Adapter Fast-Cath Hemostasis Introducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2007-11-09
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2007-11-09
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2007-11-09
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-11-09
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2007-11-09
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-11-09
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-11-09
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-08-17
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-05-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-03-21
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2009-03-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-12-05
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2012-02-06
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2012-02-06
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-03-09
JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)	Cardiovascular	Class 2	870.1750	2010-06-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-06-12
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-12-23
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2020-12-23
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2020-12-23
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-05-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2018-06-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-06-28
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2018-06-28
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-08-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-07-20
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-08-02
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-02-13
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2013-04-02
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-04-02
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-12-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-08-16
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2010-11-08
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-11-15
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2025-09-30
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2019-09-18
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2008-02-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-08-16
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2013-08-28
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-05-19
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2010-06-04
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2011-11-04
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2014-07-21
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2012-10-12
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2012-10-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-10-12
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-07-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-07-01
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2025-07-01
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2025-07-01
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2010-06-04
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2020-11-03
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-11-23
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-11-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-05-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-12-26
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-07-07
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2015-12-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-07-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-12-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-12-21
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2015-12-03
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-12-03
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-04-09
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2025-12-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2014-06-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-03-08
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-05-31
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-07-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-02-21
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-08-20
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2018-04-24
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2018-04-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-02-12
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2015-02-12
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2015-02-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2006-04-20
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-08-20
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-12-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-05-27
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2024-07-30
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-12-23
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-12-15
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-09-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-07-27
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-11-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2015-07-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-07-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-09-05
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2007-12-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-05-29
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-06-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2024-08-12
DRC	Trocar	Cardiovascular	Class 2	870.1390	2021-01-11
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2016-08-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-08-16
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2016-08-16
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2014-10-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-08-16
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-05-04
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2007-12-11
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-07-06
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2010-12-21
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2012-08-17
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2010-11-08
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-11-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-12-18
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-07-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-19
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2011-05-31
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2016-12-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-04-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2025-03-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-06-15
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-09-20
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-02-13
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-11
MOM	System, Hemodynamic, Implantable	Unknown	Class 3	N/A	2018-02-12
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-01-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-08-11
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	Class 2	870.4075	2015-05-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854482	Medtronic Vascular	ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS	1986-02-28
K790690	Cordis Corp.	OMNI-STANICOR-(THETA) MODEL 217	1979-05-16
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0004-2018	St Jude Medical Inc.	3	Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

Similar Registrations

Registration Number	Establishment Name	Location
9614453	Medtronic Europe Sarl	TOLOCHENAZ Vaud, CH
1028232	BIOTRONIK, INC.	LAKE OSWEGO, OR, US
3015453963	CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI	Maltepe Istanbul, TR
3013288201	ABBOTT MEDICAL	Minnetonka, MN, US
3006705815	Abbott Medical	Arecibo, PR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005334138. Last updated year: 2026. Please use registration number 3005334138 when referencing this establishment in official correspondence.