Stereotaxis Inc
Saint Louis, MO, US
STEREOTAXIS, INC. appears in FDA device records in Saint Louis, MO. FDA records list 28 510(k) clearances between and , 3 PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Stereotaxis Inc between 2002 and 2026. The busiest year on record is 2005, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 4 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253473 | Synchrony | DQK | Substantially Equivalent | |
| K251792 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | DXX | Substantially Equivalent | |
| K250590 | MAGiC Sweep™ EP Mapping Catheter | DRF | Substantially Equivalent | |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System | PJB | Substantially Equivalent | |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri | PJB | Substantially Equivalent | |
| K183027 | Steerable catheter control system | PJB | Substantially Equivalent | |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | DXX | Substantially Equivalent | |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | DXX | Substantially Equivalent | |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | DXX | Substantially Equivalent | |
| K133396 | VDRIVE WITH V-SONO | DQX | Substantially Equivalent | |
| K122659 | VDRIVE W/V-SONO | DQX | Substantially Equivalent | |
| K093092 | ODYSSEY WORKSTATION | DQK | Substantially Equivalent | |
| K080637 | POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS | DQX | Substantially Equivalent | |
| K072371 | ODYSSEY WORKSTATION | DXX | Substantially Equivalent | |
| K071029 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) | DQX | Substantially Equivalent | |
| K060967 | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION | NDQ | Substantially Equivalent | |
| K042850 | CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) | DQY | Substantially Equivalent | |
| K051760 | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 | DXX | Substantially Equivalent | |
| K051373 | CRONUS GUIDEWIRE, MODEL 001-001470-1 | NDQ | Substantially Equivalent | |
| K051374 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM | DQX | Substantially Equivalent | |
| K043457 | MODIFICATION TO ENDOVASCULAR GUIDE WIRE | DQX | Substantially Equivalent | |
| K042854 | STEREOTAXIS ENDOVASCULAR GUIDE WIRE | DQX | Substantially Equivalent | |
| K032937 | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 | DXX | Substantially Equivalent | |
| K021802 | STEREOTAXIS CATHETER ADVANCER SYSTEM | DQY | Substantially Equivalent | |
| K021555 | STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM | DXX | Substantially Equivalent | |
| K021363 | ENDOVASCULAR GUIDE WIRE | DQX | Substantially Equivalent | |
| K022565 | TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 | JAA | Substantially Equivalent | |
| K013484 | TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH | DRF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003084417 | 3003084417 | STEREOTAXIS, INC. | 710 N. Tucker Blvd., Suite 110, Saint Louis, MO 63101 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LPBCardiac Ablation Percutaneous Catheter
- PJBCatheter Remote Control System
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DQYCatheter, Percutaneous
- DQKComputer, Diagnostic, Programmable
- OUGMedical Device Data System
- DXXSystem, Catheter Control, Steerable
- NDQSystem, Catheter Or Guidewire, Steerable (Magnetic)
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- DQXWire, Guide, Catheter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0430-2021 | Niobe ES System, Models 001-006000-1 and 001-006100-1 | There is a potential for fire in the inside computer cabinet. | Class II | Terminated | |
| Z-0595-04 | Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1 | The magnet at the end of the guidewire could break off. | Terminated | ||
| Z-0594-04 | Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-4 | The magnet at the end of the guidewire could break off. | Terminated | ||
| Z-0593-04 | Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-3 | The magnet at the end of the guidewire could break off. | Terminated | ||
| Z-0592-04 | Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4 | The magnet at the end of the guidewire could break off. | Terminated | ||
| Z-0591-04 | Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3 | The magnet at the end of the guidewire could break off. | Terminated | ||
| Z-0590-04 | Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1 | The magnet at the end of the guidewire could break off. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain