FDA Registration
Active
🇺🇸 United States
ENSITE-DWS-04 EnSite X EP System Display Workstation
Reg #: 2184149
·
FEI: 1000139754
·
Expires 2025
Products
1
Proprietary Names
109
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- St. Jude Medical, Atrial Fibrillation Division, Inc.
- Registration Number
- 2184149
- FEI Number
- 1000139754
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- One St. Jude Medical Drive
- City
- Saint Paul
- State
- MN
- ZIP
- 55117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242016
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 |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2024-08-12 |
Proprietary Names
ENSITE-DWS-04 EnSite X EP System Display Workstation
ENSITE-R-DWS-04 EnSite X EP System Display Workstation
ENSITE-WM64-144-01 EnSite X EP System IC Output Cable
ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart
ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License
ENSITE-TFM-3.1 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade
ENSITE-ACBL-60-01 EnSite X EP System Connect Cable
ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade
ENSITE-WM56-144-01 EnSite X EP System IC Output Cable
ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License
ENSITE-TFM-03 EnSite X EP System, TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ENSITE-SW-2.1 EnSite X EP System Software Upgrade
ENSITE-LE-01 EnSite X EP System Live Export Software License
ENSITE-DWS-1.1 EnSite X EP System Display Workstation
ENSITE-DWS-01 EnSite X EP System Display Workstation
ENSITE-SYSTEM-04 EnSite X EP System
ENSITE-IMP-01 EnSite X EP System, Averaged Impedance Drop, Software License
ENSITE-R-AMP-02 EnSite X EP System Amplifier
ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable
ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set
ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ENSITE-D-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License
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-PFAGEN-01 EnSite X EP System PFA Generator Connect Cable
ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License
ENSITE-FLEX-01 EnSite X EP System, VoXel Flex, Software License
ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module
ENSITE-SW-1.2 EnSite X EP System Software Upgrade
ENSITE-HDGX-01 EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License
ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket
ENSITE-D-AMD-01 EnSite X EP System, AutoMark Distance Demo, Software License
ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor
ENSITE-LS-01 EnSite X EP System, LiveSync, Software License
ENSITE-CECG-144-01 EnSite X EP System ECG Cable
ENSITE-SYSTEM-3.1 EnSite X EP System
ENSITE-DWS-2.1 EnSite X EP System Display Workstation
ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License
ENSITE-SW-1.1 EnSite X EP System Software Upgrade
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-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License
ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module
ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License
ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable
ENSITE-DWS-3.1 EnSite X EP System, Display Workstation
ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount
ENSITE-WM56-60-01 EnSite X EP System IC Output Cable
ENSITE-FF-01 EnSite X EP System Field Frame
ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License
ENSITE-SW-03 EnSite X EP System Software Upgrade
ENSITE-D-CF-01 EnSite X EP System Contact Force Software License
ENSITE-TFM-3.2 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade
ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License
ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License
ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit
ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module
ENSITE-R-FF-01 EnSite X EP System Field Frame
ENSITE-FWV-02 EnSite X EP System, EnSite PFA Catheter Visualization Software License
ENSITE-ACBL-160-01 EnSite X EP System Connect Cable
ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount
ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand
ENSITE-D-FWV-01 EnSite X EP System, EnSite PFA Catheter Visualization Temporary, Software License
ENSITE-D-FWV-02 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License
ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License
ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart
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-SW-3.2 EnSite X EP System Software Upgrade v3.2
ENSITE-D-LS-01 EnSite X EP System, LiveSync Demo, Software License
ENSITE-D-ADASLV-01 ADAS 3D LV License Temporary Software License
ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable
ENSITE-SYSTEM-201 EnSite X EP System
ENSITE-ADASLA-01 ADAS 3D LA License Software License
ENSITE-ADASLV-01 ADAS 3D LV License Software License
ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation
ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License
ENSITE-FWV-01 EnSite X EP System EnSite PFA Catheter Visualization, Software License
ENSITE-D-FLEX-01 EnSite X EP System, VoXel Flex Demo, Software License
ENSITE-D-IMP-01 EnSite X EP System, Averaged Impedance Drop Demo, Software License
ENSITE-AAF-01 EnSite X Amplifier Air Filter
ENSITE-R-DWS-3.1 EnSite X EP System, Display Workstation
ENSITE-CECG-60-01 EnSite X EP System ECG Cable
ENSITE-SW-1.1.2 EnSite X EP System, Software Upgrade
ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module
ENSITE-ADAS-01 ADAS 3D Base License Software License
ENSITE-AMP-02 EnSite X EP System Amplifier
ENSITE-R-AMP-01 EnSite X EP System Amplifier
ENSITE-R-SYS-04 EnSite X EP System
ENSITE-OTAC-02 EnSite X EP System OTA Certificate Software License
ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit
ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart
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-D-ADASLA-01 ADAS 3D LA License Temporary Software License
ENSITE-SW-4.1 EnSite X EP System, Software Upgrade
ENSITE-AMD-01 EnSite X EP System, AutoMark Distance, Software License
ENSITE-R-DWS-01 EnSite X EP System Display Workstation
ENSITE-GENECG-NAM EnSite X EP System PFA ECG Signal Splitter
ENSITE-SYSTEM-111 EnSite X EP System
ENSITE-CF-01 EnSite X EP System Contact Force Software License
ENSITE-R-SYS-3.1 EnSite X EP System
ENSITE-ECGRL-01 EnSite X EP System, Radio-lucent ECG Lead Set
ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation
ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount
ENSITE-AMP-01 EnSite X EP System Amplifier
ENSITE-SW-2 EnSite X EP System Software Upgrade
ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device