Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012179728

FEI Number

3012179728

Entity Name

St. Jude Medical

City/State/Country

Roseville, MN, US

Establishment Address

2305 Walnut Street, Roseville, MN 55113, US

Establishment Type(s)

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

K142254

PMA Number

N/A

All Registered Proprietary Names

Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer Agilis NxT, Steerable Introducer AMPLATZER Sizing Balloon Advisor FL Circular Mapping Catheter, Sensor Enabled Reflexion Spiral Variable Radius Ca 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 Percutaneous Catheter Introducer & Removable Hemo Hemostasis Valve Adapter Fast-Cath Hemostasis Introducer Fast-Cath Trio Hemostasis Introducer 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 TactiSys Quartz Equipment TactiCath Contact Force Ablation Catheter, Sensor Enabled Ampere Generator Ampere Remote Control Ampere Generator Kit Ampere Generator Fiber Cord Assembly Remote ILUMIEN System ILUMIEN Guided Therapy System ILUMIEN Therapy Guidance System Amplatzer TorqVue LP Delivery System Inquiry AFocus II Inquiry Inquiry AFocus Advisor HD Grid X, Sensor Enabled High Density Mapping Catheter Advisor HD Grid X Mapping Catheter, Sensor Enabled 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 X EP System Amplifier EnSite X EP System EnSite Echo Module Temporary Software License EnSite X EP System EnSite X EP System RL ECG Electrode EnSite X EP System Upgrade Kit EnSite X EP System Cable Kit EnSite X EP System Display Workstation EnSite X EP System EnSite Echo Module Software License EnSite X EP System EnSite X Dual Monitor Software License EnSite X EP System, Software Upgrade EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License Safire TX Ablation Catheter Safire Duo Ablation Catheter, MediGuide Enabled Therapy Cool Path Duo Ablation Catheter Therapy Cool Flex Ablation Catheter Ampere Generator Kit Ampere Generator Cool Path Duo Ablation Catheter, MediGuide Enabled Therapy Dual-8 Ablation Catheter Therapy Cool Path Ablation Catheter Contact Therapy Cool Path Duo Ablation Catheter Ampere Generator Generator Accessories Ampere Remote Control Cool Point Irrigation Pump Therapy Ablation Catheter FemoStop Gold AMPLATZER TorqVue 45x45 Delivery Sheath 80 cm CPS Direct SL Outer Catheter-410190 Response with Lumen CPS Aim SL Slittable Inner Catheter Models DS2N021-59, DS2N021-65, DS2N022-59, DS2N022-65, DS2N023-59, DS2N023-65, DS2N024-65, DS2N025-65 ILUMIEN OPTIS System and Accessories EnSite X EP System, AutoMark Index Temporary, Software License, ENSITE-D-AMI-01 EnSite X EP System, AutoMark Index, Software License, ENSITE-AMI-01 Amplatzer TorqVue 2 Delivery Sheath Inquiry Inquiry Optima PLUS Inquiry Optima Inquiry Afocus Inquiry AFocus II DS2C022, DS2C023, DS2C024, DS2C025, DS2C026, DS2C027, DS2C028,DS2C029, DS2C030 CPS Direct Universal Slittable Outer Catheter, Models DS2C018, DS2C019, DS2C020, DS2C021 Amplatzer Muscular VSD Occluder Fast-Cath Transseptal Guiding Introducer Swartz Braided Transseptal Guiding Introducer Fast-Cath Guiding Introducer Fast-Cath Transseptal Guiding Introducer Fast-Cath Hemostasis Introducer Fast-Cath Trio Hemostasis Introducer Fast-Cath Duo Hemostasis Introducer ECG Adapter Pacel Flow Directed Pacing Catheter Disposable Patient Cables SJM Adapter Cable Connectors SJM Patient Cable 401758,401759,401760 SJM Threshold Cable 401748 SJM Epicardial Cable 401777, 401778 Abbott Medical Threshold Cable Abbott Medical Epicardial Cable Abbott Medical Patient Cable Agilis NxT Steerable Introducer Swartz Braided Transseptal Guiding Introducer Agilis NxT 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 Amplatzer Vascular Plug II (AVP II) Amplatzer Cardiac Plug (ACP) Amplatzer Duct Occluder Amplatzer Duct Occluder II Amplatzer Piccolo Occluder Amulet Steerable Delivery Sheath Amplatzer TorqVue LP Catheter Response Electrophysiology Catheter Supreme Electrophysiology Catheter Inquiry AFocus II Diagnostic Catheter Response Electrophysiology Catheter Epicardial Catheter System MediGuide Enabled Livewire Steerable Electrophysiology Catheter Livewire Steerable Electrophysiology Catheter Response Electrophysiology Catheter with Lumen Supreme Electrophysiology Catheter Fast-Cath Guiding Introducer Telesheath Guiding Introducer Advisor VL Circular Mapping Catheter, Sensor Enabled 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 Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer Agilis NxT Steerable Introducer 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 Livewire Steerable Electrophysiology Catheter MediGuide Enabled Livewire Steerable Electrophysiology Catheter Inquiry Amplatzer TorqVue Delivery System 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 Amplatzer Sizing Plate 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 EnSite X EP System Cable Kit EnSite X EP System Amplifier EnSite X EP System EnSite X Dual Monitor Software License EnSite X EP System EnSite Echo Module Temporary Software License EnSite X EP System EnSite Echo Module Software License EnSite X EP System Software Upgrade EnSite X EP System RL ECG Electrode EnSite X EP System EnSite X EP System Display Workstation EnSite X EP System Upgrade Kit Masters Series HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic) Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral) Masters Series Mechanical Heart Valve (Aortic) Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral) SJM Masters Series Mechanical Heart Valve Masters Series Mechanical Heart Valve (Mitral) Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic) SJM Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP) Regent Mechanical Heart Valve Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Aortic) Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic) Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Mitral) Regent Mechanical Heart Valve (FlexCuff) SJM Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff 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 ViewFlex Xtra ICE Catheter ViewFlex X ICE Catheter, Sensor Enabled Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Bioprosthetic Heart Valve 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 CPS Aim Universal Slittable Inner Catheter, Models DS2N026-59, DS2N027-59, DS2N028-59, DS2N026-65, DS2N027-65 CPS Aim Universal Slittable Inner Catheter, Models DS2N028-65, DS2N029-65, DS2N030-65 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) AMPLATZER Vascular Plug 4 Pacel Bipolar Pacing Catheter Safire TX Ablation Catheter Ampere Generator Therapy Dual-8 Ablation Catheter Therapy Ablation Catheter Electrophysiology Cable Ampere Generator Fiber Cord Assembly Remote Ampere Remote Control Ampere Generator Kit EnSite X EP System IC Output Cable, ENSITE-WM56-60-01 EnSite X EP System Amplifier, ENSITE-AMP-02 EnSite X EP System Display Workstation, ENSITE-DWS-1.1 EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-01 EnSite X EP System Bedrail Mount, ENSITE-RAILMNT-01 EnSite X EP System IC Output Cable, ENSITE-WM64-144-01 EnSite X EP System Amplifier Cart, ENSITE-AMPCART3-01 EnSite X EP System Wave Speed Map, ENSITE-WS-01 EnSite X EP System Field Frame, ENSITE-R-FF-01 EnSite X EP System Single Monitor Mount, ENSITE-SMMK-01 EnSite X EP System Display Workstation, ENSITE-R-DWS-1.1 EnSite X EP System Amplifier Power Module, ENSITE-AMP-EPM-01 EnSite X EP System Recording System IC Output Cable, ENSITE-CR-56-01 EnSite X EP System Live Export Software License, ENSITE-LE-01 EnSite X EP System Amplifier, ENSITE-AMP-01 EnSite X EP System EnSite Omnipolar Technology Demo, ENSITE-D-OT-01 EnSite X EP System Display Workstation Cart, ENSITE-DWSCART-01 EnSite X EP System EnSite Omnipolar Technology Data Export, ENSITE-OTEXPORT-01 EnSite X EP System Field Frame, ENSITE-FF-01 EnSite X EP System Dual Monitor Mount, ENSITE-DMMK-01 EnSite X EP System Catheter Input Module, ENSITE-CIM-80-01 EnSite X EP System EnSite Omnipolar Technology, ENSITE-OT-01 EnSite X EP System Surface Electrode Kit, ENSITE-SEK-5-01 EnSite X EP System Remote Monitor Stand, ENSITE-RMS-01 EnSite X EP System EnSite LiveView Dynamic Display, ENSITE-LV-01 EnSite X EP System Recording System IC Output Cable, ENSITE-CR-64-01 EnSite X EP System Display Workstation, ENSITE-R-DWS-01 EnSite X EP System Contact Force Software License, ENSITE-CF-01 EnSite X EP System Connect Cable, ENSITE-ACBL-60-01 EnSite X EP System Monitor Pole, ENSITE-MONPOLE-01 EnSite X EP System Field Frame Cable, ENSITE-FF-4.5C-01 EnSite X EP System IC Output Cable, ENSITE-WM64-60-01 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 Radio-lucent ECG Lead Set, ENSITE-ECGRL-01 EnSite X EP System EnSite LiveView Dynamic Display Demo, ENSITE-D-LV-01 EnSite X EP System Patient Reference Sensor, ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor, ENSITE-PRSBACK-01 EnSite X EP System Amplifier, ENSITE-R-AMP-02 EnSite X EP System IC Output Cable, ENSITE-WM56-144-01 EnSite Adjustable Field Frame Bracket, ENSITE-FF-ABRKT-01 EnSite X EP System Amplifier, ENSITE-R-AMP-01 EnSite Fixed Field Frame Bracket, ENSITE-FF-BRCKT-01 EnSite X EP System Software Upgrade, ENSITE-SW-1.1 EnSite X EP System Triple Monitor Mount, ENSITE-TMMK-01 EnSite X EP System Connect Cable, ENSITE-ACBL-160-01 EnSite X EP System Contact Force Software License, ENSITE-D-CF-01 EnSite X EP System Display Workstation, ENSITE-DWS-01 EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-01 EnSite X EP System Amplifier Cart, ENSITE-AMPCART1-01 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 ECG Cable, ENSITE-CECG-144-01 EnSite X EP System ECG Output Module, ENSITE-ECGOUT-01 CPS Direct SL II Slittable Outer Catheter DS2C001, DS2C002, DS2C003, DS2C004, DS2C005, DS2C006, DS2C011, DS2C012, DS2C013, DS2C014, DS2C015 CPS Universal II Slitter Model DS2A004 CPS Universal Slitter Model DS2A003 Rigid Saddle Ring SJM Rigid Saddle Ring Electrophysiology Cable Cardioverter Cable Response Electrophysiology Extension Cable 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 CPS Excel MediGuide Enabled Guidewire, Model DS2M033, DS2M027, DS2M028, DS2M029, DS2M030

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-12-18
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-08-20
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2017-02-17
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2016-10-31
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2016-12-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-08-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-11-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-05-19
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2014-10-25
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2017-05-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2024-07-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-06-30
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-04-07
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2020-03-24
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2012-10-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2006-04-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-02-26
MAE	Occluder, Patent Ductus, Arteriosus	Unknown	Class 3	N/A	2015-09-11
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2015-09-11
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-08-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-03-16
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2017-05-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-09-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-02-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-11-21
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2017-02-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-06-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2007-12-11
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2007-12-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-04-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
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	2025-12-22
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
MAE	Occluder, Patent Ductus, Arteriosus	Unknown	Class 3	N/A	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-09-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-11
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2010-12-21
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2015-07-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2019-09-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-07-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-08-02
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2008-02-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2015-07-17
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-09-27
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-02-21
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2017-02-17
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-08-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-12-04
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2007-10-16
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
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-09-04
LWR	Heart-Valve, Non-Allograft Tissue	Unknown	Class 3	N/A	2011-04-21
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2011-04-21
JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)	Cardiovascular	Class 2	870.1750	2010-06-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-11-21
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-05-31
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-02-17
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2012-12-06
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2007-12-07
NGV	System, Appendage Closure, Left Atrial	Unknown	Class 3	N/A	2021-08-14
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-02-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-02-25
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2007-12-11
KRH	Ring, Annuloplasty	Cardiovascular	Class 2	870.3800	2007-10-16
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2020-03-24
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
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-11-21

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.

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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
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012179728. Last updated year: 2026. Please use registration number 3012179728 when referencing this establishment in official correspondence.