Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2184149

FEI Number

1000139754

Entity Name

St. Jude Medical, Atrial Fibrillation Division, Inc.

City/State/Country

Saint Paul, MN, US

Establishment Address

One St. Jude Medical Drive, Saint Paul, MN 55117, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,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

N/A

PMA Number

P220013

All Registered Proprietary Names

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 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 EnSite Velocity System v.4.2 EnSite Precision Mapping Module Upgrade Kit EnSite Contact Force Module PressureWire Aeris / Certus (Gen 8) ViewFlex Catheter Interface Module EnSite Velocity System EE3000 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-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 AMP-TFDM-01 Ampere Generator Software Upgrade TSQ-V1.8-TFDM-01 TactiSys Quartz Equipment Software Upgrade Radi Analyzer Xpress Adapter 12748 PressureWire Net PW USB Receiver AO USB Receiver Wi-box Wi-Box AO Transmitter, Signal Transmitter 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 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 EP-WorkMate System ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License ENSITE-R-DWS-01 EnSite X EP System Display Workstation ENSITE-DWS-01 EnSite X EP System Display Workstation ENSITE-D-CF-01 EnSite X EP System Contact Force Software License ENSITE-WM56-144-01 EnSite X EP System IC Output Cable ENSITE-AMP-02 EnSite X EP System Amplifier ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit ENSITE-SW-2 EnSite X EP System Software Upgrade ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand EnSite X EP System Level Order Number ENSITE-SYSTEM-201 ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module ENSITE-AMP-01 EnSite X EP System Amplifier ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade ENSITE-ACBL-160-01 EnSite X EP System Connect Cable ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled 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-WM64-60-01 EnSite X EP System IC Output Cable ENSITE-SW-2.1 EnSite X EP System Software Upgrade ENSITE-R-AMP-01 EnSite X EP System Amplifier ENSITE-DWS-1.1 EnSite X EP System Display Workstation ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License ENSITE-R-FF-01 EnSite X EP System Field Frame ENSITE-ACBL-60-01 EnSite X EP System Connect Cable ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module ENSITE-SW-1.2 EnSite X EP System Software Upgrade ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation ENSITE-R-AMP-02 EnSite X EP System Amplifier ENSITE-FF-01 EnSite X EP System Field Frame ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module ENSITE-SW-1.1 EnSite X EP System Software Upgrade ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount ENSITE-CF-01 EnSite X EP System Contact Force Software License ENSITE-LE-01 EnSite X EP System Live Export Software License ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License ENSITE-ECGRL-01 EnSite X EP System Radio-lucent ECG Lead set ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License ENSITE-WM56-60-01 EnSite X EP System IC Output Cable ENSITE-CECG-144-01 EnSite X EP System ECG Cable EnSite X EP System Level Order Number ENSITE-SYSTEM-111 ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount ENSITE-DWS-2.1 EnSite X EP System Display Workstation ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart ENSITE-WM64-144-01 EnSite X EP System IC Output Cable ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License EnSite NavX Surface Electrode Kit EnSite Array Multi-electrode Diagnostic Catheter EnSite Velocity System v.3 EnSite Velocity System OneModel 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 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 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 EnSite X EP System, AutoMark Index Temporary, Software License, ENSITE-D-AMI-01 EnSite X EP System, AutoMark Index, Software License, ENSITE-AMI-01 Ensite Velocity Cardiac Mapping System V.2, Ensite Precision Cardiac Mapping System V2.2 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 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 EnSite X EP System, Software Upgrade 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 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) 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 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 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 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 Ampere Generator Cool Point Irrigation Pump Cool Point Tubing Set Ampere Generator Fiber Cord Assembly Remote Ampere Remote Control Ampere Generator Kit Cool Point Irrigation Pump Pressure Alarm Adapter Cable Electrophysiology Cable 1779 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 Velocity Cardiac Mapping System V.2, Ensite Precision Cardiac Mapping System V2.2 EnSite Velocity System v.4 EnSite Velocity System Version 4 EnSite Precision Mapping Module 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-02-21
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2020-03-24
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2014-06-10
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
DRJ	System, Signal Isolation	Cardiovascular	Class 1	870.2600	2010-11-29
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2012-08-17
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2007-12-07
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-08-11
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2014-02-14
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2011-11-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-12-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-02-21
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2010-06-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-09-19
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-11-23
JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)	Cardiovascular	Class 2	870.1750	2010-06-04
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2007-12-11
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2025-03-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-09-05
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-11-15
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
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2008-02-13
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-05-21
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-02-02
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-12-15
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-05-31
MOM	System, Hemodynamic, Implantable	Unknown	Class 3	N/A	2018-02-12
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	2020-07-07
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-04-07
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-02-13
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2008-02-13
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	2018-11-15
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2013-05-08
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-05-19

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
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
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

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3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
3003084417	STEREOTAXIS, INC.	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2184149. Last updated year: 2026. Please use registration number 2184149 when referencing this establishment in official correspondence.