EnSite Precision Adjustable Field Frame Bracket

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: K201181

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	2020-07-07

Proprietary Names

EnSite Precision Adjustable Field Frame Bracket Ensite Velocity Amplifier Cart Ensite Velocity System Equipotential Cable Ensite Velocity EP-WorkMate Record Connect Ensite Courier Software Installation v.3 30 Day Trial, H702501-T Ensite Verismo Software Upgrade Kit v.2.1 Ensite Velocity Software Upgrade Kit, v5.2 Ensite Velocity ArrayLink Module Ensite Velocity System EP-WorkMate RecordConnect Ensite Precision Software Installation v.2.1 Ensite Precision Software Installation Ensite Velocity System Workstation Accessory Kit Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) RFB EnSite Precision Surface Electrode Kit, PRCN-SEK-A Printer Ensite Precision Field Frame, H702469 Ensite Velocity System RecordConnect Kit Universal Ensite Precision Software Installation v.2.2 Ensite Precision Field Frame Storage Bracket EnSite Velocity Surface Electrode Kit Large, 5 Pack EN0010-10000331 Advisor FL Mapping Catheter, Sensor Enabled Software Installation, H702507 Ensite Velocity Kit, GenConnect, Stockert, NST Ensite Display Workstation, EE3000 Ensite Velocity System Workstation Cart AutoMark Software Installation v.1, H702499 Ensite Velocity System Siemens RecordConnect Ensite System GenConnect (GenConnect interface to Atakr generator.) GenConnect Ensite Contact Force Module Installation Kit, H702500-HW Ensite Velocity Display Workstation (DWS) Ensite Velcity System Display Workstation Kit Ensite Velocity Amplifier and Display Workstation Ensite Velocity Software Upgrade Kit, v5.2.1 Ensite Velocity System GE CardioLab RecordConnect Ensite System GenConnect (GenConnect Interface to EPT generator.) RFB Ensite Velocity Amplifier and DWS Ensite Velocity System Monitor 24" Ensite Contact Force Module Software Installation, v.2, H702500 Ensite Precision Field Frame Bracket, H702472 EnSite Precision Surface Electrode Kit Ensite Velocity System GenConnect (GenConnect interface to Stockert generator.) Ensite Velocity System GenConnect Kit IBI Ensite Velocity NavLink Module Ensite Velocity Display Workstation DWS Kit Ensite Velocity RecordConnect For Use With WorkMate Claris System Ensite Velocity Bard Clearsign RecordConnect Ensite Velocity System GenConnect (GenConnect interface to T-series generator.) FlexAbility Ablation Catheter, Sensor Enabled Software Installation Power Cord, Compatible with St. Jude Medical Electrophysiology Products Ensite AutoMap Module v.1, H702498 Ensite Precision Field Frame Bracket, H702472-E Ensite Velocity Amplifier Ensite Fusion Software Upgrade Kit v.7.1, H702506 Ensite Velocity System RecordConnect Ensite Velocity Software Upgrade Kit, v5.1 Ensite Velocity System CathLink Module EnSite System Reference Electrode, SYS-REF-V1 Ensite Precision Field Frame Cable, Ensite Velcity System GenConnect (GenConnect interface to Stockert generator.) Ensite Velocity Display Workstation AutoMark Installation Kit, H702499-HW EnSite Precision Patient Reference Sensor SURF-ELEC-2PRS Ensite Precision Software Installation v.2.1 30 Day Trial Ensite Velocity System DWS Kit Ensite MediGuide Interface Module Software Installation v.1.1, H702503 Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, H702519 Ensite Velocity System Amplifier Cart Ensite Precision Bedrail Mount Kit, H702474 Ensite Velocity System GenConnect (GenConnect interface to Stockert SmartAblate generator.) Ensite Amplifier and Display Workstation, EE3000 Ensite Velocity CathLink Module Ensite Velocity Cable Assembly Kit, T Series Ensite Velocity System RecordConnect (RecordConnect interface to Bard Clearsign recording system.) TactiCath Ablation Catheter, Sensor Enabled Software Installation Ensite Derexi Module v.1.3.1, H702502 Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled, H702532 Ensite Velocity System Amplifier Kit Ensite Precision Software Installation v.2.2 30 Day Trial TactiCath Ablation Catheter, Sensor Enabled Catheter Catalog Installation, v.1 Record Connect Ensite Velocity Workstation Cart Ensite System RecordConnect RFB Ensite Velocity Remote Monitor Stand Ensite Velocity Sytstem Workstation Ensite Precision Power Supply Kit Ensite Velocity System Workstation Ensite Contact Force Module Software Installation, H702500 Remote Monitor Stand Ensite Contact Force Module Software Installation v.2 30 Day License, H702500-T Ensite System GenConnect (GenConnect Interface to EPT generator.) Ensite Velocity DWS HDD TactiCath Ablation Catheter, Sensor Enabled Software Installation 30 Day Trial Ensite Velocity System Cable Accessory Kit Ensite Precision Software Installation v.2 30 Day Trial Ensite Velocity System Remote Monitor Stand Ensite AutoMap Module v.1 30 Day Trial, H702498-T Ensite Precision Link, Sensor Enabled Link EnSite Precision Module, Sensor Enabled Module Ensite Velocity System GenConnect Ensite Precision Patient Reference Sensor Ensite System GenConnect (GenConnect interface to Atakr generator.) RFB Ensite System RecordConnect (RecordConnect interface to Bard Stamp recording system.) Ensite Courier Software Installation v.3, H702501 Ensite System RecordConnect Ensite Velocity RecordConnect EnSite NavLink Module, Surface Electrode Connector EnSite CathLink Module, Catheter Input Module EnSite ArrayLink Module, Catheter Input Module EnSite GenConnect Module, Generator Connector EnSite RecordConnect Module, Recording System Connector

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device