FDA.reportPublic FDA data

Cardiac mapping system workstation

Definition
A mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory.
GUDID devices
49
Last updated
2025-11-28 14:11:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07290019564003LIBERTY Endovascular Robotic SystemMICROBOT MEDICAL LTDLIBERTYOS2025-11-18
07290019564058LIBERTY Endovascular Robotic System - robotMICROBOT MEDICAL LTDLIBERTYOS2025-11-18
07290019564102LIBERTY Endovascular Robotic System - armMICROBOT MEDICAL LTDLIBERTYOS2025-11-18
M58800100175110QuikCAS Cardiodrive Sterile ComponentsStereotaxis, Inc.12016-05-02
M5880010017711QuikCAS Hemostasis AdapterStereotaxis, Inc.12016-08-01
M5880010017712Cardiodrive Hemostasis Adapter - SJStereotaxis, Inc.12016-08-01
M58800100230710Vdrive SystemStereotaxis, Inc.Single Arm2016-08-01
M58800100230720Vdrive SystemStereotaxis, Inc.Duo2016-08-01
M58800100242210V-CAS Catheter Advancement SystemStereotaxis, Inc.12016-05-02
M58800100245210V-Loop Variable Loop Catheter ManipulatorStereotaxis, Inc.12016-05-02
M58800100246910V-Sono Intracardiac Echo ManipulatorStereotaxis, Inc.12016-05-02
M58800100411590Cardiodrive SystemStereotaxis, Inc.II2016-08-01
M58800100591011Niobe Cover DrapeStereotaxis, Inc.12016-08-01
M58800100600010Niobe MNS SiemensStereotaxis, Inc.ES Siemens2016-08-01
M58800100610010Niobe MNS PhilipsStereotaxis, Inc.ES Philips2016-08-01
M58800100701020OdysseyStereotaxis, Inc.Quad HD2016-08-01
M58800100781010Odyssey Enterprise InterfaceStereotaxis, Inc.EIF2016-08-01
M58800100784010Odyssey CinemaStereotaxis, Inc.Studio2016-08-01
M58800100790010OdysseyStereotaxis, Inc.Link2016-08-01
M58800101005611Vdrive DrapeStereotaxis, Inc.12016-08-01
M588020004500210NavigantStereotaxis, Inc.4.6.42016-08-01
M588020004500220NavigantStereotaxis, Inc.4.6.52016-08-01
M588020004500260NavigantStereotaxis, Inc.5.0.22016-10-27
M588020004500360NavigantStereotaxis, Inc.5.0.72022-06-06
00860007954115vMap DisposablesVektor Medical, Inc.VMDISP22022-11-15
00860007954122vMap Control UnitVektor Medical, Inc.VMCU22022-11-15
00816280023185CorPath GRX Cassette DuoCORINDUS, INC.3192022-08-08
M58800100111410Hemostasis AdapterSTEREOTAXIS, INC.IV-12021-12-14
00815671020246Sensei®HANSEN MEDICAL, INC.082572016-09-30
00815671020260Sensei®HANSEN MEDICAL, INC.SRS2002016-09-30
00815671020284Magellan™HANSEN MEDICAL, INC.111322016-09-30
00815671020314Magellan™HANSEN MEDICAL, INC.MTS1002016-09-30
00815671020321Magellan™HANSEN MEDICAL, INC.MAR1002016-09-30
00816280022010CorPath 200 Control ConsoleCorindus, Inc.160-000432016-09-24
00816280022027CorPath 200 Articulated ArmCorindus, Inc.160-008072016-09-24
00816280022034CorPath 200 Robotic DriveCorindus, Inc.160-000502016-09-24
00816280022041CorPath 200 CassetteCorindus, Inc.160-00173-NC2016-09-24
00816280022072CorPath 200 POGO Pin CapsCorindus, Inc.160-008762016-09-24
00816280022096CorPath 200 Control Console DrapeCorindus, Inc.160-009812016-09-24
00816280022119CorPath 200 Joystick CoversCorindus, Inc.160-006922016-09-24
00816280022133CorPath 200 Robotic Drive DrapeCorindus, Inc.160-008282016-09-24
00816280023017CorPath GRX Control ConsoleCorindus, Inc.3012017-01-20
00816280023024CorPath GRX Extended Reach ArmCorindus, Inc.3022017-01-20
00816280023031CorPath GRX Robotic DriveCorindus, Inc.3032017-01-20
00816280023055CorPath GRX CassetteCorindus, Inc.3052017-01-20
00816280023079CorPath GRX Drive GearCorindus, Inc.3072017-01-20
00816280023093CorPath GRX Drape, Robotic Drive and ArmCorindus, Inc.3092017-01-20
00816280023116CorPath GRX Drape, Control ConsoleCorindus, Inc.3112017-01-20
00816280023123CorPath GRX Extended Reach ArmCorindus, Inc.3122018-04-05