510(k) K012952 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
| Applicant | Boston Scientific/Medi-Tech, Natick, MA, US |
| Decision | Substantially Equivalent, Oct 2, 2001 |
| Received | Sep 4, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012952
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2010 | Maquet Cardiovascular, LLC Hemashield Gold Woven Double Velour Vascular Branch Graft Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.