Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008452825

FEI Number

3008452825

Entity Name

Abbott Medical Costa Rica Ltda.

City/State/Country

El Coyol Alajuela, CR

Establishment Address

Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol, El Coyol Alajuela 1897-4050, CR

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

K243493

PMA Number

N/A

All Registered Proprietary Names

Agilis NxT Steerable Introducer ViewFlex Xtra ICE Catheter ViewFlex X ICE 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 Advisor FL Circular Mapping Catheter, Sensor Enabled 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 Agilis NxT Introducer 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 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 Advisor VL Circular Mapping Catheter, Sensor Enabled Epicardial Catheter System Advisor HD Grid Mapping Catheter, Sensor Enabled ViewFlex Xtra ICE Catheter 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 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 Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer Agilis NxT Steerable Introducer 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 Response Electrophysiology Catheter Epicardial Catheter System MediGuide Enabled Livewire Steerable Electrophysiology Catheter Livewire Steerable Electrophysiology Catheter Response Electrophysiology Catheter with Lumen Supreme Electrophysiology Catheter 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 ViewFlex Xtra ICE Catheter D087031 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 EnSite Precision Cardiac Mapping System, v2.1 EnSite Precision Surface Electrode Kit TactiSys Quartz Equipment TactiCath Contact Force Ablation Catheter, Sensor Enabled Ampere Generator Ampere Remote Control Ampere Generator Kit Ampere Generator Fiber Cord Assembly Remote ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License ENSITE-R-FF-01 EnSite X EP System Field Frame ENSITE-R-AMP-01 EnSite X EP System Amplifier ENSITE-FF-01 EnSite X EP System Field Frame ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License ENSITE-R-AMP-02 EnSite X EP System Amplifier ENSITE-SW-1.2 EnSite X EP System Software Upgrade ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set ENSITE-DWS-01 EnSite X EP System Display Workstation ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade ENSITE-CECG-60-01 EnSite X EP System ECG Cable ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable ENSITE-SW-1.1 EnSite X EP System Software Upgrade ENSITE-WM56-144-01 EnSite X EP System IC Output Cable ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module ENSITE-CECG-144-01 EnSite X EP System ECG Cable ENSITE-CF-01 EnSite X EP System Contact Force Software License ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable EnSite X EP System Level Order Number ENSITE-SYSTEM-111 ENSITE-ECGRL-01 EnSite X EP System Radio-lucent ECG Lead set ENSITE-LE-01 EnSite X EP System Live Export Software License ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole ENSITE-SW-2.1 EnSite X EP System Software Upgrade ENSITE-ACBL-60-01 EnSite X EP System Connect Cable ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation ENSITE-WM64-144-01 EnSite X EP System IC Output Cable ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit ENSITE-R-DWS-01 EnSite X EP System Display Workstation ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License ENSITE-D-CF-01 EnSite X EP System Contact Force Software License ENSITE-DWS-1.1 EnSite X EP System Display Workstation ENSITE-DWS-2.1 EnSite X EP System Display Workstation ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License ENSITE-ACBL-160-01 EnSite X EP System Connect Cable ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor ENSITE-WM64-60-01 EnSite X EP System IC Output Cable ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation ENSITE-SW-2 EnSite X EP System Software Upgrade ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module ENSITE-AMP-01 EnSite X EP System Amplifier ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License ENSITE-WM56-60-01 EnSite X EP System IC Output Cable EnSite X EP System Level Order Number ENSITE-SYSTEM-201 ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License ENSITE-AMP-02 EnSite X EP System Amplifier ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer Agilis NxT, Steerable Introducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-09-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-06-30
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	2007-12-07
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-04-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-02-26
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
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	2019-09-18
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-08-19
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
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-11-21
DRC	Trocar	Cardiovascular	Class 2	870.1390	2021-01-11
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-05-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-08-02
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
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2015-07-17
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-07-07
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2023-01-05
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2024-08-12
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-12-13
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2014-10-25
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-02-02
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

Barb Scherber Email: barb.scherber@abbott.com Phone: (651) 7567518

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
K243493	ABBOTT MEDICAL	Agilis NxT Steerable Introducer Dual-Reach	2024-12-13
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

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-0003-2016	Biosense Webster, Inc.	2	SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
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.

Similar Registrations

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3017689643	CARDIOVIA Ltd.	Nazareth Northern, IL
3041086754	PULNOVO MEDICAL (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008452825. Last updated year: 2026. Please use registration number 3008452825 when referencing this establishment in official correspondence.