510(k) K010517 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
ADVANTA SST GRAFT (<6MM)
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, May 18, 2001 |
| Received | Feb 22, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2013 | Atrium Medical Corporation Advanta SST Grafts <6mm
Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.