510(k) K961847 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
HEMASHIELD VANTAGE (VASCULAR GRAFT
| Applicant | Meadox Medicals, Div. Boston Scientific Corp., Oakland NJ, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jan 22, 1997 |
| Received | May 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961847
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2005 | Boston Scientific Corporation Hemashield Vantage Vascular Graft. Vascular graft prosthesis. Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.