FDA Registration
Active
🇺🇸 United States
Ensite Fusion Software Upgrade Kit v.7.1
Reg #: 3005334138
·
FEI: 3005334138
·
Expires 2025
Products
1
Proprietary Names
99
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- St. Jude Medical, Cardiology Division, Inc.
- Registration Number
- 3005334138
- FEI Number
- 3005334138
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5050 Nathan Lane North
- City
- Plymouth
- State
- MN
- ZIP
- 55442
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183128
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 | 2018-12-17 |
Proprietary Names
Ensite Fusion Software Upgrade Kit v.7.1
Ensite Velocity System GenConnect (GenConnect interface to Stockert generator.)
Ensite Precision Field Fram Bracket
Ensite Precision Link, Sensor Enabled Link
Ensite Velocity CathLink Module
Ensite Precision Bedrail Mount Kit
AutoMark Installation Kit
Ensite Velocity System GenConnect Kit IBI
Ensite Velocity Remote Monitor Stand
Ensite Velocity System RecordConnect Kit Universal
Ensite Velcity System GenConnect (GenConnect interface to Stockert generator.)
Ensite Derexi Module v.1.3.1
Ensite Velocity NavLink Module
Ensite Velocity Cable Assembly Kit, T Series
Ensite Courier Software Installation v.3
Ensite Velocity RecordConnect For Use With WorkMate Claris System
Ensite AutoMap Module v.1
Ensite Precision Field Frame Storage Bracket
Ensite Contact Force Module Software Installation v.2 30 Day License
Ensite Velocity Sytstem Workstation
AutoMark Software Installation v.1
Ensite Velocity Amplifier
Ensite System GenConnect (GenConnect Interface to EPT generator.)
Ensite Velocity System GenConnect
Ensite Velocity RecordConnect
Ensite Precision Field Frame Bracket
Ensite Precision Module, Sensor Enabled Module
Power Cord, Compatible with St. Jude Medical Electrophysiology Products
Ensite Velcity System Display Workstation Kit
Ensite MediGuide Interface Module Software Installation v.1.1
Ensite Velocity Workstation Cart
Ensite Velocity Software Upgrade Kit, v5.1
Ensite Verismo Software Upgrade Kit v.2.1
Printer
Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) RFB
Ensite Velocity System Cable Accessory Kit
Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.)
Ensite Velocity System CathLink Module
Ensite Velocity System Monitor 24"
Ensite Velocity Amplifier Cart
Ensite Precision Patient Reference Sensor
Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation
Ensite Precision Field Frame
Ensite Velocity System Equipotential Cable
Ensite Velocity System RecordConnect
Ensite Velocity System GE CardioLab RecordConnect
Ensite Amplifier and Display Workstation
Ensite Velocity ArrayLink Module
GenConnect
Ensite Contact Force Module Software Installation
Ensite Precision Software Installation
Ensite Velocity EP-WorkMate Record Connect
Ensite Velocity System Workstation Cart
Ensite Display Workstation
Ensite Precision Field Frame Cable
Ensite Velocity Software Upgrade Kit, v5.2.1
Ensite Velocity Amplifier and Display Workstation
TactiCath Ablation Catheter, Sensor Enabled Software Installation 30 Day Trial
Ensite Velocity Kit, GenConnect, Stockert, NST
Ensite System GenConnect (GenConnect interface to Atakr generator.) RFB
Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled
TactiCath Ablation Catheter, Sensor Enabled Software Installation
Ensite Velocity Display Workstation (DWS)
Ensite Precision Software Installation v.2.2
Ensite System RecordConnect
Ensite Velocity System Siemens RecordConnect
Record Connect
Ensite Velocity System Workstation Accessory Kit
Ensite Velocity System Amplifier Kit
Ensite Contact Force Module Installation Kit
Ensite Precision Software Installation v.2 30 Day Trial
Advisor FL Mapping Catheter, Sensor Enabled Software Installation
Ensite Velocity System Amplifier Cart
Ensite Velocity System GenConnect (GenConnect interface to T-series generator.)
Ensite Velocity Amplifier and DWS
Ensite Precision Software Installation v.2.1
Ensite Velocity Bard Clearsign RecordConnect
Ensite System RecordConnect RFB
Ensite Velocity System EP-WorkMate RecordConnect
FlexAbility Ablation Catheter, Sensor Enabled Software Installation
Ensite AutoMap Module v.1 30 Day Trial
Remote Monitor Stand
Ensite Velocity System Remote Monitor Stand
TactiCath Ablation Catheter, Sensor Enabled Catheter Catalog Installation, v.1
Ensite Contact Force Module Software Installation, v.2
Ensite Velocity Software Upgrade Kit, v5.2
Ensite Velocity System Workstation
Ensite Velocity Display Workstation DWS Kit
Ensite Velocity Display Workstation
Ensite Velocity System RecordConnect (RecordConnect interface to Bard Clearsign recording system.)
Ensite Courier Software Installation v.3 30 Day Trial
Ensite Precision Software Installation v.2.1 30 Day Trial
Ensite System GenConnect (GenConnect Interface to EPT generator.) RFB
Ensite System GenConnect (GenConnect interface to Atakr generator.)
Ensite Precision Power Supply Kit
Ensite Velocity System GenConnect (GenConnect interface to Stockert SmartAblate generator.)
Ensite Velocity System DWS Kit
Ensite Velocity DWS HDD
Ensite Precision Software Installation v.2.2 30 Day Trial
Establishment Types
Complaint File Establishment per 21 CFR 820.198