510(k) K021363 ยท DQX Wire, Guide, Catheter
ENDOVASCULAR GUIDE WIRE
| Applicant | Stereotaxis, Inc., Saint Louis MO, US |
| Decision | Substantially Equivalent, Nov 27, 2002 |
| Received | Apr 30, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Stereotaxis Inc Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1 Terminated |
NFN | None listed |
| Jul 20, 2004 | Stereotaxis Inc Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3 Terminated |
NFN | None listed |
| Jul 20, 2004 | Stereotaxis Inc Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4 Terminated |
NFN | None listed |
| Jul 20, 2004 | Stereotaxis Inc Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-3 Terminated |
NFN | None listed |
| Jul 20, 2004 | Stereotaxis Inc Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-4 Terminated |
NFN | None listed |
| Jul 20, 2004 | Stereotaxis Inc Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1 Terminated |
NFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.