FDA Registration
Active
🇺🇸 United States
St. Jude Medical, Cardiology Division, Inc.
Reg #: 3005334138
·
FEI: 3005334138
·
Expires 2026
Products
41
Proprietary Names
713
Establishment Types
4
Classifications
41
Registration Details
- Registration Name
- St. Jude Medical, Cardiology Division, Inc.
- Registration Number
- 3005334138
- FEI Number
- 3005334138
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5050 Nathan Lane North
- City
- Plymouth
- State
- MN
- ZIP
- 55442
- Country
- US
Regulatory Submissions
- 510(k) Number
- K260212
- PMA Number
- P880006
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2007-11-09 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2007-11-09 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2007-11-09 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2007-11-09 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2007-11-09 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2007-11-09 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2007-11-09 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1992-08-17 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2026-05-21 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2014-03-21 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2009-03-03 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2008-12-05 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2012-02-06 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2012-02-06 |
| Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | JOQ | Class 2 | Cardiovascular | No | 2010-06-04 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2020-12-23 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2020-12-23 |
| Transducer, Pressure, Catheter Tip | DXO | Class 2 | Cardiovascular | No | 2018-06-28 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2018-06-28 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2013-04-02 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2025-09-30 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2008-02-13 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2023-05-19 |
| Cannula, Catheter | DQR | Class 2 | Cardiovascular | No | 2014-07-21 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2020-11-03 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2025-12-22 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2015-12-04 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2006-04-20 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2021-01-11 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2007-12-11 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2011-05-31 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2007-12-11 |
| System, Hemodynamic, Implantable | MOM | Class 3 | Unknown | No | 2018-02-12 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2015-05-04 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2019-03-01 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2016-03-07 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2016-03-07 |
| System, Signal Isolation | DRJ | Class 1 | Cardiovascular | No | 2010-11-29 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2012-10-12 |
Proprietary Names
Merlin Patient Care System Software Model 3330 Version 18.1.1
Regency family of pacemakers
REPOSITIONING SLEEVE
EnSite X EP System, Software Upgrade
Ultimum
Ultimum Introducer
RadiStop
HydroSteer
Ampere Generator
FlexAbility Ablation Catheter
Sensor Enabled Ablation Connection Cable
Therapy Cool Flex Ablation Catheter
FlexAbility Ablation Catheter, Sensor Enabled
Therapy Cool Path Duo Ablation Catheter
Safire BLU Duo Ablation Catheter
IBI 1500T9-CP V1.6 Cardiac Ablation Generator
Ampere Generator Accessories
Ampere Generator Fiber Cord Assembly Remote
Ampere Generator Kit
Ampere Remote Control
Ampere Footswitch
WorkMate Claris System
EP-4 Cardiac Stimulator
EP-4 Cardiac Stimulator, Keyboard
EP-4 Cardiac Stimulator, Cardiac Stimulator
EP-4 Cardiac Stimulator, Cardiac Stimulator Cable
EP-4 Cardiac Stimulator, Touch Screen Computer
Fast-Cath Transseptal Guiding Introducer
Swartz Braided Transseptal Guiding Introducer
EnSite X EP System Dual Monitor Mount, ENSITE-DMMK-01
EnSite X EP System Amplifier, ENSITE-AMP-01
Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-F15
EnSite X EP System Single Monitor Mount, ENSITE-SMMK-01
EnSite X EP System ECG Cable, ENSITE-CECG-144-01
EnSite X EP System IC Output Cable, ENSITE-WM56-60-01
EnSite Fixed Field Frame Bracket, ENSITE-FF-BRCKT-01
EnSite X EP System Amplifier Power Module, ENSITE-AMP-EPM-01
EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-01
EnSite X EP System Patient Reference Sensor, ENSITE-PRSFRNT-01
EnSite X EP System Connect Cable, ENSITE-ACBL-60-01
EnSite X EP System IC Output Cable, ENSITE-WM64-144-01
EnSite X EP System Amplifier, ENSITE-AMP-02
EnSite X EP System Field Frame Cable, ENSITE-FF-4.5C-01
EnSite X EP System Patient Reference Sensor, ENSITE-PRSBACK-01
EnSite X EP System IC Output Cable, ENSITE-WM64-60-01
Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-F20
EnSite X EP System Surface Electrode Kit, ENSITE-SEK-5-01
EnSite X EP System Amplifier Cart, ENSITE-AMPCART1-01
Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-V1525
Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF20-V1525
EnSite X EP System Recording System IC Output Cable, ENSITE-CR-56-01
EnSite X EP System ECG Cable, ENSITE-CECG-60-01
EnSite X EP System Catheter Input Module, ENSITE-CIM-20-01
EnSite X EP System Recording System IC Output Cable, ENSITE-CR-64-01
EnSite X EP System Remote Monitor Stand, ENSITE-RMS-01
EnSite X EP System Amplifier, ENSITE-R-AMP-02
EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-01
Advisor HD Grid High Density Mapping Catheter, Sensor Enabled, D-AVHD-DF16
EnSite X EP System Monitor Pole, ENSITE-MONPOLE-01
EnSite X EP System Catheter Input Module, ENSITE-CIM-80-01
EnSite Adjustable Field Frame Bracket, ENSITE-FF-ABRKT-01
EnSite X EP System Field Frame Cable, ENSITE-FF-3MC-01
Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-F15
EnSite X EP System Contact Force Software License, ENSITE-CF-01
EnSite X EP System Display Workstation, ENSITE-DWS-01
EnSite X EP System Amplifier Cart, ENSITE-AMPCART3-01
Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D20-V1525
EnSite X EP System ECG Output Module, ENSITE-ECGOUT-01
EnSite X EP System Connect Cable, ENSITE-ACBL-160-01
Advisor VL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-V1525
EnSite X EP System Display Workstation, ENSITE-R-DWS-01
EnSite X EP System Contact Force Software License, ENSITE-D-CF-01
EnSite X EP System Amplifier, ENSITE-R-AMP-01
EnSite X EP System Triple Monitor Mount, ENSITE-TMMK-01
Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-DF10-F20
EnSite X EP System Field Frame, ENSITE-FF-01
EnSite X EP System Bedrail Mount, ENSITE-RAILMNT-01
EnSite X EP System IC Output Cable, ENSITE-WM56-144-01
EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-01
EnSite X EP System Display Workstation Cart, ENSITE-DWSCART-01
EnSite X EP System Field Frame, ENSITE-R-FF-01
EnSite Velocity System v.4
EnSite Velocity System Version 4
EnSite Precision Mapping Module
Agilis NxT Steerable Introducer
PressureWire X
Engage TR Introducer
Inquiry
Inquiry Luma-Cath
Agilis NxT
Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer
Agilis NxT Steerable Introducer
Ampere RF Ablation Generator
Therapy Ablation Catheter
Grounding Cable 1710
Electrophysiology Cable
Ensite Velocity System GenConnect (GenConnect interface to Stockert generator.)
Ensite Precision Field Fram Bracket
Ensite Velocity DWS HDD
Ensite Precision Software Installation v.2.2 30 Day Trial
Ensite Precision Bedrail Mount Kit
TactiCath Ablation Catheter, Sensor Enabled Software Installation 30 Day Trial
Ensite Velocity Software Upgrade Kit, v5.1
Printer
Ensite System GenConnect (GenConnect Interface to EPT generator.) RFB
Ensite Velocity System Equipotential Cable
Ensite Precision Software Installation
Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.)
Ensite Velocity System CathLink Module
Ensite Courier Software Installation v.3
Ensite Velocity RecordConnect For Use With WorkMate Claris System
Ensite Fusion Software Upgrade Kit v.7.1
Ensite Precision Field Frame Storage Bracket
Ensite Courier Software Installation v.3 30 Day Trial
Ensite Display Workstation
Ensite Velocity Amplifier Cart
Ensite Precision Patient Reference Sensor
Ensite Verismo Software Upgrade Kit v.2.1
Ensite Velocity Display Workstation (DWS)
AutoMark Software Installation v.1
Ensite System RecordConnect RFB
Ensite Velocity System EP-WorkMate RecordConnect
Ensite Velocity System Remote Monitor Stand
Ensite Velocity ArrayLink Module
GenConnect
Ensite Velocity System Workstation Cart
Ensite Velocity System GenConnect (GenConnect interface to Stockert SmartAblate generator.)
Ensite Velocity System DWS Kit
Ensite Velocity Amplifier and Display Workstation
Ensite Velocity CathLink Module
Ensite Contact Force Module Software Installation v.2 30 Day License
Ensite Velocity Sytstem Workstation
Ensite Velocity System Workstation Accessory Kit
Ensite Velocity System Amplifier Kit
Ensite System GenConnect (GenConnect Interface to EPT generator.)
Ensite Velocity System Cable Accessory Kit
Record Connect
Ensite Velocity System Monitor 24"
Ensite Precision Field Frame Cable
Ensite Velocity Software Upgrade Kit, v5.2.1
Ensite Velocity Display Workstation DWS Kit
Ensite Velocity Kit, GenConnect, Stockert, NST
Ensite Velocity Display Workstation
Ensite Velocity NavLink Module
Ensite Velocity System Amplifier Cart
Ensite Velocity Amplifier
Ensite Velocity System GenConnect
Ensite Derexi Module v.1.3.1
Ensite Precision Link, Sensor Enabled Link
AutoMark Installation Kit
Ensite Precision Software Installation v.2.1
TactiCath Ablation Catheter, Sensor Enabled Catheter Catalog Installation, v.1
Ensite Velocity RecordConnect
Ensite Velocity Cable Assembly Kit, T Series
Ensite Velocity System RecordConnect Kit Universal
Ensite Velocity System GE CardioLab RecordConnect
Ensite Amplifier and Display Workstation
Ensite Precision Field Frame Bracket
Ensite Velcity System GenConnect (GenConnect interface to Stockert generator.)
Ensite AutoMap Module v.1 30 Day Trial
Ensite Contact Force Module Software Installation
Remote Monitor Stand
Power Cord, Compatible with St. Jude Medical Electrophysiology Products
Ensite Velocity System GenConnect (GenConnect interface to T-series generator.)
Ensite Velocity Bard Clearsign RecordConnect
Ensite Velocity Software Upgrade Kit, v5.2
Ensite Contact Force Module Software Installation, v.2
Ensite Velcity System Display Workstation Kit
Ensite Velocity Workstation Cart
Ensite Velocity System Workstation
Ensite Precision Field Frame
Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled
Ensite System RecordConnect
TactiCath Ablation Catheter, Sensor Enabled Software Installation
Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation
Ensite Velocity System RecordConnect
Ensite Velocity EP-WorkMate Record Connect
Ensite Precision Software Installation v.2.2
Ensite Velocity System Siemens RecordConnect
Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) RFB
Ensite MediGuide Interface Module Software Installation v.1.1
Ensite Velocity Amplifier and DWS
Ensite System GenConnect (GenConnect interface to Atakr generator.) RFB
Ensite Precision Software Installation v.2.1 30 Day Trial
Ensite Velocity System GenConnect Kit IBI
Ensite Velocity Remote Monitor Stand
FlexAbility Ablation Catheter, Sensor Enabled Software Installation
Ensite Velocity System RecordConnect (RecordConnect interface to Bard Clearsign recording system.)
Ensite Contact Force Module Installation Kit
Ensite Precision Module, Sensor Enabled Module
Ensite Precision Software Installation v.2 30 Day Trial
Advisor FL Mapping Catheter, Sensor Enabled Software Installation
Ensite System GenConnect (GenConnect interface to Atakr generator.)
Ensite Precision Power Supply Kit
Ensite AutoMap Module v.1
Engage Introducer
MediGuide Enabled Livewire Steerable EP Catheter
Ensite Velocity Cardiac Mapping System V.2, Ensite Precision Cardiac Mapping System V2.2
Disposable RF Electrode (RFDE-5, RFDE-10, RFDE-15, RFDE-20)
Advisor VL Circular Mapping Catheter, Sensor Enabled
Sensor Enabled Diagnostic Connection Cable
Reflexion Spiral EP Extension Adaptor
EnSite X EP System Catheter Connector Cable, D-ENS-AVSE-5-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-SUP-D-CBL
Response Electrophysiology Extension Cable
Supreme Electrophysiology Cable
EnSite X EP System Catheter Connector Cable, D-ENS-INQ-OD-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-AVSE-6-CBL
Electrophysiology Extension Cable
EnSite X EP System Catheter Connector Cable, D-ENS-L/R-HOD-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-INQ-Q-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-SUP-Q-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-SUP-DDY-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-L/R-BQ-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-INQ-DD-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-SUP-H-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-L/R-DDY-CBL
EnSite X EP System, Catheter Connector Cable, A-ENS-MAGEXT-CBL
Sensor Enabled Cable, Diagnostic Catheter Cable
EnSite X EP System Catheter Connector Cable, ICE-VFSE-2D-CBL
EnSite X EP System Catheter Connector Cable, D-ENS-AVHDX-CBL
Ultimum Hemostasis Introducer
IBI-1100 Bi-Directional Steerable Electrophysiology Catheter System
Inquiry Steerable Diagnostic Catheter
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-DD-X
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-JJ-X
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-FJ
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-D
TactiFlex Sensor Enabled Ablation Catheter - A-TFSE-J
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 Generator
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-F-X
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-DF-X
TactiFlex Sensor Enabled, Ablation Catheter - A-TFSE-D-X
EP-WorkMate System
Radi Analyzer Xpress Adapter 12748
PressureWire Net
PW USB Receiver
AO USB Receiver
Wi-box
Wi-Box AO Transmitter, Signal Transmitter
Repositioning Sleeve
PressureWire Receiver
PressureWire Aeris Agile Tip
PressureWire Certus Agile Tip
Advisor HD Grid Sensor Enabled, High Density Mapping Catheter
ViewFlex Eco, Reprocessed ICE Catheter
Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer
Agilis NxT, Steerable Introducer
Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter
ViewFlex Xtra, ICE Catheter
EP-NurseMate
EP-NurseMate with Physio Module
IonicRF Generator
EnSite NavX Surface Electrode Kit
EnSite Array Multi-electrode Diagnostic Catheter
EnSite Velocity System v.3
EnSite Velocity System OneModel
ViewFlex Xtra ICE Catheter
GuideRight Guidewires
Fast-Cath Transseptal Guiding Introducer
Ensite Precision Field Frame Cable,
Ensite Amplifier and Display Workstation, EE3000
Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, H702519
Ensite Precision Field Frame Bracket, H702472
Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled, H702532
Ensite AutoMap Module v.1, H702498
Ensite AutoMap Module v.1 30 Day Trial, H702498-T
EnSite Precision Surface Electrode Kit, PRCN-SEK-A
Ensite Derexi Module v.1.3.1, H702502
EnSite Precision Surface Electrode Kit
AutoMark Installation Kit, H702499-HW
Ensite Precision Bedrail Mount Kit, H702474
EnSite Precision Patient Reference Sensor SURF-ELEC-2PRS
EnSite Precision Module, Sensor Enabled Module
Ensite Precision Field Frame, H702469
AutoMark Software Installation v.1, H702499
Ensite Fusion Software Upgrade Kit v.7.1, H702506
Ensite Contact Force Module Software Installation, H702500
Ensite Contact Force Module Software Installation v.2 30 Day License, H702500-T
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 Surface Electrode Kit Large, 5 Pack EN0010-10000331
Ensite Courier Software Installation v.3, H702501
Ensite Contact Force Module Installation Kit, H702500-HW
Ensite Courier Software Installation v.3 30 Day Trial, H702501-T
Ensite Display Workstation, EE3000
Ensite MediGuide Interface Module Software Installation v.1.1, H702503
EnSite Precision Adjustable Field Frame Bracket
EnSite CathLink Module, Catheter Input Module
EnSite GenConnect Module, Generator Connector
EnSite RecordConnect Module, Recording System Connector
EnSite NavLink Module, Surface Electrode Connector
EnSite ArrayLink Module, Catheter Input Module
Ultimum EV Hemostasis Introducer
'PEEL-AWY INTRO KIT
SMK Radiofrequency Needle
Sheath Obturator
Current PFA Radiolucent ECG Lead Set
Current PFA ECG Trunk Cable
Volt PFA Kit
Current PFA Catheter Input Module
Current PFA Unified Cable
Current PFA Generator Cart
Current PFA Recording System Connect Cable
Volt PFA Catheter, Sensor Enabled
Current PFA Radiopaque ECG Lead Set
Current PFA Generator
Current PFA Generator Software Upgrade
Cables
EnSite Velocity System v.4.2
EnSite Precision Mapping Module Upgrade Kit
EnSite Contact Force Module
Peel Away Introducer kit replacement syringe accessory Models 405104, 405108, 405112, 405116, 405118, 405119, 405120, 40
Bedrail Clamp- 100007639
EnSite Velocity Stockert GenConnect (Refurb) - 100047843
EnSite X EP System Contact Force Software License, ENSITE-D-CFLF-01
EnSite X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-I-01
Power Kit OUS-H702505
EnSite X EP System ECG Output Module, ENSITE-ECGOUT-I-01
TactiCath Ablation Catheter, Sensor Enabled, Catheter Catalog Installation, v.1 - H702518
EnSite X EP System Contact Force Software License, ENSITE-CFLF-01
EnSite X EP System SurfaceLink Module, ENSITE-SRFLNK-I-01
Recorder Interconnect Kit, Bard V5 - 75-04629-002
Ensite Velocity Intl Power Kit - 100019046
EnSite Velocity Ablation Cable Kit, Stockert - 75-04469-003
EnSite System (RFB GenConnect interface to Atakr generator) - 100039379
EnSite Velocity Ablation Cable Kit, IFI, T9 - 75-05392-001
EnSite Verismo, Software Installation, v.2.x - H00001
EnSite X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-I-01
EnSite System GenConnect (GenConnect interface to EPT generator) - 100038592
EnSite Velocity Amplifier Cart - H710002
EnSite Precision Module - Hardware- H702473
TactiCath Ablation Catheter, Sensor Enabled, Software Installation, 30 Day Trial - H702517-T
EnSite X EP System TactiFlex Ablation Catheter Sensor Enabled Software Upgrade, ENSITE-TFM-01
RecordConnect (Universal Refurb) - 100040093
EnSite X EP System TactiFlex Ablation Catheter Sensor Enabled Software License, ENSITE-TF-01
WorkMate Claris System, Power Kit, China
WorkMate Scribe Module
ENSITE-GENECG-OUS EnSite X EP System PFA ECG Signal Splitter
EnSite X EP System, PFA Index, Software License (ENSITE-PI-01)
EnSite X EP System, TactiFlex Duo Ablation Catheter, Sensor Enabled Temporary, Software License (ENSITE-D-FOCAL-01)
EnSite X EP System, EnSite AI Geo Temporary Software License, ENSITE-D-AGL-01
EnSite X EP System, EnSite AI Geo Software License, ENSITE-AG-01
EnSite X EP System, PFA Index Temporary, Software License (ENSITE-D-PI-01 )
EnSite X EP System, TactiFlex Duo Ablation Catheter, Sensor Enabled, Software License (ENSITE-FOCAL-01)
TigerWire GuideWires
EnSite X EP System EnSite Omnipolar Technology Data Export, ENSITE-OTEXPORT-01
EnSite X EP System Display Workstation, ENSITE-DWS-1.1
EnSite X EP System Software Upgrade, ENSITE-SW-1.1.2
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 EnSite Omnipolar Technology, ENSITE-OT-01
EnSite X EP System Software Upgrade, ENSITE-SW-1.1
EnSite X EP System Live Export Software License, ENSITE-LE-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 Wave Speed Map Demo, ENSITE-D-WS-01
EnSite X EP System Display Workstation, ENSITE-R-DWS-1.1
Reflexion Spiral Variable Radius Ca
Advisor HD Grid Mapping Catheter, Sensor Enabled
PressureWire Aeris / Certus (Gen 8)
CPS Direct SL Outer Catheter-410190
Response with Lumen
Classic Radiofrequency Cannula
Advisor HD Grid X, Sensor Enabled High Density Mapping Catheter
Advisor HD Grid X Mapping Catheter, Sensor Enabled
ViewFlex X ICE Catheter, Sensor Enabled
Maximum Hemostasis Introducer
Contamination Cover/Protective Cap
Maximum
Fast-Cath Guiding Introducer
FastCath Hemostasis Introducer
EnSite X EP System, AutoMark Index Temporary, Software License, ENSITE-D-AMI-01
EnSite X EP System, AutoMark Index, Software License, ENSITE-AMI-01
Safire Bi-Directional Catheter
Livewire TC Ablation Catheter
Safire Catheter Extension Cable
Fast-Cath Hemostasis Introducer
Fast-Cath Trio Hemostasis Introducer
Fast-Cath Duo Hemostasis Introducer
GuiderRight Guidewires
EnSite LiveView Dynamic Display Software License
EnSite Precision Software Installation v2.6
EnSite Precision Software Upgrade v2.7.1
EnSite Precision Software Installation v.2.7 H702701
EnSite Precision Surface Electrode Kit EN0020-p
EnSite Precision System Software Upgrade v.2.6.1, H702602
ENSITE-R-SYS-04 EnSite X EP System
ENSITE-SYSTEM-04 EnSite X EP System
ENSITE-D-ADASLA-01 ADAS 3D LA License Temporary Software License
ENSITE-ADASLV-01 ADAS 3D LV License Software License
ENSITE-CECG-60-01 EnSite X EP System ECG Cable
ENSITE-OTAC-02 EnSite X EP System OTA Certificate Software License
ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module
ENSITE-SW-1.1 EnSite X EP System Software Upgrade
ENSITE-IMP-01 EnSite X EP System, Averaged Impedance Drop, Software License
ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License
ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade
ENSITE-SW-03 EnSite X EP System Software Upgrade
ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole
ENSITE-SW-3.1 EnSite X EP System, Software Upgrade
ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket
ENSITE-ACBL-60-01 EnSite X EP System Connect Cable
ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart
ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable
ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart
ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount
ENSITE-TFM-03 EnSite X EP System, TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ENSITE-R-AMP-01 EnSite X EP System Amplifier
ENSITE-TFM-3.1 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade
ENSITE-AMD-01 EnSite X EP System, AutoMark Distance, Software License
ENSITE-WM64-60-01 EnSite X EP System IC Output Cable
ENSITE-DWS-3.1 EnSite X EP System, Display Workstation
ENSITE-CF-01 EnSite X EP System Contact Force Software License
ENSITE-FF-01 EnSite X EP System Field Frame
ENSITE-SYSTEM-3.1 EnSite X EP System
ENSITE-AAF-01 EnSite X Amplifier Air Filter
ENSITE-SW-1.1.2 EnSite X EP System, Software Upgrade
ENSITE-R-FF-01 EnSite X EP System Field Frame
ENSITE-FWV-02 EnSite X EP System, EnSite PFA Catheter Visualization Software License
ENSITE-D-LS-01 EnSite X EP System, LiveSync Demo, Software License
ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand
ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License
ENSITE-SYSTEM-201 EnSite X EP System
ENSITE-ACBL-160-01 EnSite X EP System Connect Cable
ENSITE-DWS-1.1 EnSite X EP System Display Workstation
ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License
ENSITE-GENECG-NAM EnSite X EP System PFA ECG Signal Splitter
ENSITE-WM64-144-01 EnSite X EP System IC Output Cable
ENSITE-HDGX-01 EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License
ENSITE-D-AMD-01 EnSite X EP System, AutoMark Distance Demo, Software License
ENSITE-D-ADASLV-01 ADAS 3D LV License Temporary Software License
ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit
ENSITE-SW-2 EnSite X EP System Software Upgrade
ENSITE-CECG-144-01 EnSite X EP System ECG Cable
ENSITE-D-IMP-01 EnSite X EP System, Averaged Impedance Drop Demo, Software License
ENSITE-DWS-2.1 EnSite X EP System Display Workstation
ENSITE-R-DWS-3.1 EnSite X EP System, Display Workstation
ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module
ENSITE-R-SYS-3.1 EnSite X EP System
ENSITE-D-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License
ENSITE-R-DWS-04 EnSite X EP System Display Workstation
ENSITE-SW-3.2 EnSite X EP System Software Upgrade v3.2
ENSITE-WM56-144-01 EnSite X EP System IC Output Cable
ENSITE-D-FWV-02 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License
ENSITE-ADAS-01 ADAS 3D Base License Software License
ENSITE-AMP-02 EnSite X EP System Amplifier
ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation
ENSITE-D-FLEX-01 EnSite X EP System, VoXel Flex Demo, Software License
ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit
ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License
ENSITE-D-FWV-01 EnSite X EP System, EnSite PFA Catheter Visualization Temporary, Software License
ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable
ENSITE-SW-3.1.1 EnSite X EP System Software Upgrade
ENSITE-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Software License
ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set
ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket
ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable
ENSITE-TFM-3.2 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade
ENSITE-FLEX-01 EnSite X EP System, VoXel Flex, Software License
ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License
ENSITE-R-DWS-01 EnSite X EP System Display Workstation
ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation
ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License
ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable
ENSITE-ECGRL-01 EnSite X EP System, Radio-lucent ECG Lead Set
ENSITE-LE-01 EnSite X EP System Live Export Software License
ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount
ENSITE-DWS-01 EnSite X EP System Display Workstation
ENSITE-AMP-01 EnSite X EP System Amplifier
ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License
ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor
ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License
ENSITE-R-AMP-02 EnSite X EP System Amplifier
ENSITE-SW-2.1 EnSite X EP System Software Upgrade
ENSITE-FWV-01 EnSite X EP System EnSite PFA Catheter Visualization, Software License
ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module
ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License
ENSITE-SW-1.2 EnSite X EP System Software Upgrade
ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount
ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor
ENSITE-LS-01 EnSite X EP System, LiveSync, Software License
ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart
ENSITE-SYSTEM-111 EnSite X EP System
ENSITE-WM56-60-01 EnSite X EP System IC Output Cable
ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License
ENSITE-D-CF-01 EnSite X EP System Contact Force Software License
ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module
ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module
ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License
ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License
ENSITE-OTAC-03 EnSite X EP System OTA Certificate Software License
ENSITE-PFAGEN-01 EnSite X EP System PFA Generator Connect Cable
ENSITE-ADASLA-01 ADAS 3D LA License Software License
ENSITE-DWS-04 EnSite X EP System Display Workstation
BRK XS Series Transseptal Needle G407211
BRK XS Series Transseptal Needle G407208
BRK-1 XS Series Transseptal Needle G407209
BRK-1 Transseptal Needle 407201
BRK XS Series Transseptal Needle G407210
BRK Transseptal Needle 407205
BRK-1 XS Series Transseptal Needle G407212
BRK-1 XS Series Transseptal Needle G407216
BRK Transseptal Needle 407206
BRK Transseptal Needle 407200
BRK-1 Transseptal Needle 407207
BRK Transseptal Needle G407215
TactiSys Quartz Equipment
TactiCath Contact Force Ablation Catheter, Sensor Enabled
ViewFlex Eco Reprocessed ICE Catheter D087031-R
Inquiry AFocus II Diagnostic Catheter
EnSite Velocity System
EE3000
Livewire Steerable Electrophysiology Catheter
WorkMate Claris System, Cable Kit
WorkMate Claris System, ECG Cable Set, Radiopaque
Radiotranslucent Leadwire
Kit ECG Cable Radio-Translucent 36in Brn
Mouse, PS2, Wired
WM Claris Additional Monitor Cable Kit
Cable Assy, Stim, EP4
Catheter Input Module 1-56
Cable Assy, IBP, Baxter Truwave
Cable Assy, IBP, Merit Meritrans
v.1.2.1 Onyx Scribe Upgrade Kit
Fiber Optic Cable - Duplex LC/LC
Power Supply Connector Adapter
WorkMate ImageSync Module
WM Claris CPU
Ferrite, Round Cable Snap-its, 200MHz-10
Kit WM Claris V1.1 Upgrade
WM Claris Z440 v.1.2 Upgrade Kit
Cable Assy, IBP, Namic Preceptors DT
WM Scribe Onyx v.1.2 Upgrade Kit
Media Conv, DB9 to Fiber SC
Cable Assy, IBP, Abbott Transpac IV
Cable Assy, IBP, Maxxim Cobe
SCU II Assembly 448 Channel
EP-4 Stimulator System 110V
USB Optical Scroll Mouse, Wired
v.1.2.1 Z440 Upgrade Kit
S-Video to VGA Signal Converter
Power Conditioner, 120 VAC, 1440 VA Medi
Cable Assy, IBP, Medex 960
SCU II Assembly 96 Channel
DVI to HDMI Adapter
LCD Dual Monitor Mount Kit
Reverse IEC Accessory Power Strip
WM Unity Review Module - 10 User License
Monitor, Touch Screen LCD, 19 Inch
Media Conv, SC Fiber to DB9
Cable Assy, IBP, Omedha DTXX
EP-WorkMate/EP-4 USB Keyboard
WorkMate Scribe Module 110V with Physio
USB Keyboard, Wired, English
DVI to DisplayPort Adapter
WM Claris Power Kit, 110
Power Conditioner, 120 VAC, 600 VA,
Cable Assy, IBP, Medex 860
WorkMate Claris System, Bed Rail Kit
Keyboard, PS2, Wired
2-port DVI splitter
Cable Equipotential
v.1.2.1 Z620 Upgrade Kit
WorkMate Claris System, System - Display Plus
WorkMate Claris System, Generic Stimulator Cable
WorkMate Scribe CPU
Ferrite round cable snap its 1 to 300MHz
WM Unity Review Mod - Sgl User License
WorkMate Scribe Module
Monitor, LCD, 16:9 1920x1080 Resolution
WorkMate Unity DICOM Module
4 Outlet Reverse IEC Accessory Power Str
Cable Assy, IBP, Utah Deltran
WM Claris Z620 v.1.2 Upgrade Kit
Cable Assy, IBP, Medex 950
WorkMate Claris System Display Workstation
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
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, Bracket Bottom Shelf Computer Bench
WorkMate Claris System, ECG Cable
WorkMate Scribe Module, Display Workstation
ViewFlex Eco Reprocessed ICE catheter
Seal-Away Introducer
Peel-Away Introducer
VantageView
Telesheath Guiding Introducer
Advisor FL Circular Mapping Catheter, Sensor Enabled
Peel-Awy
Agilis NxT Introducer
Fast-Cath Trio Hemostasis Introducer
PFA-GEN-OVERLAY-F Current PFA Overlay
A-VOLT-01 Volt PFA Catheter, Sensor Enabled
PFA-TSQ-CBL Current PFA TactiSys Connect Cable
TactiFlex Duo Sensor Enabled Ablation Catheter
PFA-AMP-RETURN-CBL Current PFA Ampere Return Electrode Cable
PFA-GEN-OVERLAY Current PFA Overlay
PFA-GEN-V110 Current PFA Generator Software Upgrade
WorkMate Claris System
Inquiry Optima PLUS
Inquiry Optima
Inquiry Afocus
Inquiry AFocus II
SJM Vessel Dilator
CardioMEMS HF System
CardioMEMS Hospital Electronics System
CardioMEMS Patient Electronics System
Merlin.net Patient Care Network Heart Failure Portal
CardioMEMS PA Sensor and Delivery System
CardioMEMS Hospital System
CardioMEMS HERO Device
ENSITE-ECGRL-01 EnSite X EP System Radio-lucent ECG Lead set
Procure Endomyocardial Biopsy Forceps
Percutaneous Catheter Introducer & Removable Hemo
Hemostasis Valve Adapter
Fast-Cath Hemostasis Introducer
AMPLATZER Guidewires
GuideRight GuideWires
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
QUANTIEN Measurement System with Software Version 1.12.1
Livewire Steerable Electrophysiology Catheter
MediGuide Enabled Livewire Steerable Electrophysiology Catheter
Engage/Engage TR Introducer
Epicardial Catheter System
Reflexion Spiral
ViewFlex Xtra ICE Catheter D087031
Inquiry AFocus
EnSite X EP System Level Order Number ENSITE-SYSTEM-111
EnSite X EP System Level Order Number ENSITE-SYSTEM-201
Cool Point Irrigation Pump
Cool Point Tubing Set
Cool Point Irrigation Pump Pressure Alarm Adapter Cable
Electrophysiology Cable 1779
Response Electrophysiology Catheter
Supreme Electrophysiology Catheter
ViewMate Ultrasound Console
RadiAnalyzer Xpress Monitor Cable 12900 Series
Quantien Measurement System
Quantien Mounting Stands and Brackets
Quantien Measurement System Monitor Cables C12900 Series
RadiAnalyzer Xpress Cable Converter C12784
Quantien Measurement System Adapter C12600 series
Quantien Measurement System AUX OUT Cable C12796
Quantien Measurement System C12787
RadiAnalyzer Adapter Cables 12600 series
Quantien Measurement System AUX IN Cable C12500-C12510
Reflexion HD Mapping Catheter
MG1000
MediGuide Technology
ViewFlex Catheter Interface Module
Safire TX Ablation Catheter
Therapy Dual-8 Ablation Catheter
Therapy Ablation Catheter
EnSite Array Catheter
EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License
Disposable Electrodes
EnSite Precision Cardiac Mapping System, v2.1
Abbott Medical Grounding Pad
RF Grounding Pad (model RF-DGP-IZ)
FemoStop Gold
Response Electrophysiology Catheter
Response Electrophysiology Catheter with Lumen
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only