FDA 510(k) Applications Submitted by Stereotaxis, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080637 |
03/06/2008 |
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS |
STEREOTAXIS, INC. |
| K060967 |
04/07/2006 |
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION |
STEREOTAXIS, INC. |
| K071029 |
04/11/2007 |
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) |
STEREOTAXIS, INC. |
| K072371 |
08/23/2007 |
ODYSSEY WORKSTATION |
STEREOTAXIS, INC. |
| K093092 |
10/01/2009 |
ODYSSEY WORKSTATION |
STEREOTAXIS, INC. |
| K141530 |
06/09/2014 |
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS |
STEREOTAXIS, INC. |
| K133396 |
11/06/2013 |
VDRIVE WITH V-SONO |
STEREOTAXIS, INC. |
| K140804 |
03/31/2014 |
VDRIVE WITH V-LOOP/ VDRIVE DUO |
STEREOTAXIS, INC. |
| K021363 |
04/30/2002 |
ENDOVASCULAR GUIDE WIRE |
STEREOTAXIS, INC. |
| K042850 |
10/15/2004 |
CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) |
STEREOTAXIS, INC. |
| K042854 |
10/15/2004 |
STEREOTAXIS ENDOVASCULAR GUIDE WIRE |
STEREOTAXIS, INC. |
| K043457 |
12/15/2004 |
MODIFICATION TO ENDOVASCULAR GUIDE WIRE |
STEREOTAXIS, INC. |
| K021802 |
06/03/2002 |
STEREOTAXIS CATHETER ADVANCER SYSTEM |
STEREOTAXIS, INC. |
| K122659 |
08/31/2012 |
VDRIVE W/V-SONO |
STEREOTAXIS, INC. |
| K150312 |
02/09/2015 |
Vdrive system, Vdrive Duo, Vdrive with V-Sono |
STEREOTAXIS, INC. |
| K051373 |
05/26/2005 |
CRONUS GUIDEWIRE, MODEL 001-001470-1 |
STEREOTAXIS, INC. |
| K051374 |
05/26/2005 |
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM |
STEREOTAXIS, INC. |
| K192775 |
09/30/2019 |
Niobe« Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri |
Stereotaxis, Inc. |
| K183027 |
11/01/2018 |
Steerable catheter control system |
Stereotaxis, Inc. |
| K193147 |
11/13/2019 |
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System |
Stereotaxis, Inc. |
| K021555 |
05/13/2002 |
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM |
STEREOTAXIS, INC. |
| K051760 |
06/29/2005 |
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 |
STEREOTAXIS, INC. |
| K022565 |
08/02/2002 |
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 |
STEREOTAXIS, INC. |
| K032937 |
09/22/2003 |
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 |
STEREOTAXIS, INC. |
| K013484 |
10/19/2001 |
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH |
STEREOTAXIS, INC. |
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