Medical Device Manufacturer · US , St. Louis , MO

Stereotaxis, Inc.

27 submissions · 27 cleared · Since 2002
27
Total
27
Cleared
0
Denied

Stereotaxis, Inc. — FDA 510(k) Submissions

Stereotaxis, Inc. has submitted 27 FDA 510(k) premarket notifications since 2002, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wire, Guide, Catheter, System, Catheter Control, Steerable, Catheter Remote Control System, Catheter, Percutaneous, System, Catheter Or Guidewire, Steerable (magnetic) . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
Stereotaxis GenesisX RMN with Navigant ? Workstation (NWS)
K251792 · DXX System, Catheter Control,... · Cardiovascular
Nov 2025 148d
MAGiC Sweep? EP Mapping Catheter
K250590 · DRF Catheter, Electrode... · Cardiovascular
Jul 2025 146d
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
K193147 · PJB Catheter Remote Control... · Cardiovascular
Mar 2020 113d
Niobe? Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
K192775 · PJB Catheter Remote Control... · Cardiovascular
Oct 2019 30d
Steerable catheter control system
K183027 · PJB Catheter Remote Control... · Cardiovascular
Sep 2019 309d
Vdrive system, Vdrive Duo, Vdrive with V-Sono
K150312 · DXX System, Catheter Control,... · Cardiovascular
Jun 2015 128d
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS
K141530 · DXX System, Catheter Control,... · Cardiovascular
Dec 2014 192d
VDRIVE WITH V-LOOP/ VDRIVE DUO
K140804 · DXX System, Catheter Control,... · Cardiovascular
Sep 2014 156d
VDRIVE WITH V-SONO
K133396 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 2014 92d
VDRIVE W/V-SONO
K122659 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2013 329d
ODYSSEY WORKSTATION
K093092 · DQK Computer, Diagnostic,... · Cardiovascular
Jan 2010 112d
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
K080637 · DQX Wire, Guide, Catheter · Cardiovascular
Aug 2008 159d
ODYSSEY WORKSTATION
K072371 · DXX System, Catheter Control,... · Cardiovascular
Nov 2007 83d
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
K071029 · DQX Wire, Guide, Catheter · Cardiovascular
Aug 2007 135d
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
K060967 · NDQ System, Catheter Or... · Neurology
Oct 2006 195d
CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
K042850 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2006 663d
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
K051760 · DXX System, Catheter Control,... · Cardiovascular
May 2006 310d
CRONUS GUIDEWIRE, MODEL 001-001470-1
K051373 · NDQ System, Catheter Or... · Neurology
Dec 2005 197d
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
K051374 · DQX Wire, Guide, Catheter · Cardiovascular
Jun 2005 28d
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
K043457 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 2005 75d
STEREOTAXIS ENDOVASCULAR GUIDE WIRE
K042854 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 2005 116d
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
K032937 · DXX System, Catheter Control,... · Cardiovascular
Jul 2004 283d
STEREOTAXIS CATHETER ADVANCER SYSTEM
K021802 · DQY Catheter, Percutaneous · Cardiovascular
Apr 2003 309d
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
K021555 · DXX System, Catheter Control,... · Cardiovascular
Jan 2003 247d
ENDOVASCULAR GUIDE WIRE
K021363 · DQX Wire, Guide, Catheter · Cardiovascular
Nov 2002 211d
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