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STEREOTAXIS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30030844173003084417STEREOTAXIS, INC.1N2026-01-01710 N. Tucker Blvd., Suite 110 Saint Louis MO US 63101

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M588001004115110Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.13146786100info@stereotaxis.com
M588001004115120Cardiodrive System - The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.13146786100info@stereotaxis.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
598311856688661P240014MAGiC Ablation CatheterLPB2026-01-05
598311079046906K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)DXX2025-11-06
598311291271560K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB2020-03-05
598311086521175K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB2019-10-30
598311753160422K150312Vdrive system, Vdrive Duo, Vdrive with V-SonoDXX2015-06-17
598311503724748K141530VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CASDXX2014-12-18
598312031835693K140804VDRIVE WITH V-LOOP/ VDRIVE DUODXX2014-09-03
598311045182920K133396VDRIVE WITH V-SONODQX2014-02-06
598311638739304K122659VDRIVE W/V-SONODQX2013-07-26
598311606842181K093092ODYSSEY WORKSTATIONDQK2010-01-21
598312051785781K072371ODYSSEY WORKSTATIONDXX2007-11-14
598311666462778K071029CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)DQX2007-08-24
598311471315869K060967NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATIONNDQ2006-10-19
598311895911417

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXX52025-11-06
DQX32014-02-06
PJB22020-03-05
DQK12010-01-21
NDQ12006-10-19

PMN#

GUDID#

GenesisX - Stereotaxis GenesisX RMN with Navigant™ Workstation (NWS) and Cardiodrive® System (GenesisX) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) using computer-controlled permanent magnets to orient or steer the tip of a magnetic device, and remotely advance and retract only compatible magnetic electrophysiology (EP) catheters inside the patient’s heart. GenesisX incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

Stereotaxis, Inc.

2026-01-09

Vdrive System - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """

Stereotaxis, Inc.

2016-08-01

Vdrive System - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """

Stereotaxis, Inc.

2016-08-01

Vdrive Drape - """The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during theperformance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance ofelectrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when usedin conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic NavigationSystem (MNS). """

Stereotaxis, Inc.

2016-08-01