ENSITE-WM64-60-01 EnSite X EP System IC Output Cable

Registration Details

Registration Name: St. Jude Medical
Registration Number: 3012179728
FEI Number: 3012179728
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 2305 Walnut Street
City: Roseville
State: MN
ZIP: 55113
Country: US

Regulatory Submissions

510(k) Number: K231415

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	2023-08-11

Proprietary Names

ENSITE-WM64-60-01 EnSite X EP System IC Output Cable ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit ENSITE-D-AMD-01 EnSite X EP System, AutoMark Distance Demo, Software License ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License ENSITE-SYSTEM-111 EnSite X EP System ENSITE-DWS-1.1 EnSite X EP System Display Workstation ENSITE-R-FF-01 EnSite X EP System Field Frame ENSITE-WM56-144-01 EnSite X EP System IC Output Cable ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License 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-R-DWS-1.1 EnSite X EP System Display WorkStation ENSITE-ACBL-60-01 EnSite X EP System Connect Cable ENSITE-IMP-01 EnSite X EP System, Averaged Impedance Drop, Software License ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation ENSITE-FLEX-01 EnSite X EP System, VoXel Flex, Software License ENSITE-DWS-01 EnSite X EP System Display Workstation ENSITE-FF-01 EnSite X EP System Field Frame ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License ENSITE-SW-2.1 EnSite X EP System Software Upgrade ENSITE-SW-2 EnSite X EP System Software Upgrade ENSITE-SW-1.1 EnSite X EP System Software Upgrade ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable ENSITE-TFM-3.2 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade ENSITE-CF-01 EnSite X EP System Contact Force Software License ENSITE-LE-01 EnSite X EP System Live Export Software License ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount ENSITE-AMP-01 EnSite X EP System Amplifier ENSITE-ACBL-160-01 EnSite X EP System Connect Cable ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount ENSITE-D-LS-01 EnSite X EP System, LiveSync Demo, Software License ENSITE-AMD-01 EnSite X EP System, AutoMark Distance, Software License 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-CR-56-01 EnSite X EP System Recording System IC Output Cable ENSITE-D-FWV-01 EnSite X EP System, EnSite PFA Catheter Visualization Temporary, Software License ENSITE-SYSTEM-201 EnSite X EP System ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set ENSITE-WM64-144-01 EnSite X EP System IC Output Cable ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket ENSITE-WM56-60-01 EnSite X EP System IC Output Cable ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit ENSITE-AAF-01 EnSite X Amplifier Air Filter ENSITE-CECG-60-01 EnSite X EP System ECG Cable 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-R-DWS-01 EnSite X EP System Display Workstation ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand ENSITE-ECGRL-01 EnSite X EP System Radio-lucent ECG Lead set ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module ENSITE-R-AMP-02 EnSite X EP System Amplifier ENSITE-CECG-144-01 EnSite X EP System ECG Cable ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module ENSITE-SW-03 EnSite X EP System Software Upgrade ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket ENSITE-D-CF-01 EnSite X EP System Contact Force Software License ENSITE-ECGRL-01 EnSite X EP System, Radio-lucent ECG Lead Set ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License ENSITE-D-FLEX-01 EnSite X EP System, VoXel Flex Demo, Software License ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module ENSITE-DWS-2.1 EnSite X EP System Display Workstation ENSITE-AMP-02 EnSite X EP System Amplifier ENSITE-SW-3.2 EnSite X EP System Software Upgrade v3.2 ENSITE-SW-1.2 EnSite X EP System Software Upgrade ENSITE-SW-1.1.2 EnSite X EP System, Software Upgrade ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount ENSITE-R-AMP-01 EnSite X EP System Amplifier ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License ENSITE-LS-01 EnSite X EP System, LiveSync, Software License ENSITE-D-IMP-01 EnSite X EP System, Averaged Impedance Drop Demo, Software License

Establishment Types

Manufacture Medical Device