510(k) K984294 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
| Applicant | Intervascular, Inc., Clearwater FL, US |
| Decision | Substantially Equivalent, Feb 22, 1999 |
| Received | Dec 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984294
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2022 | Maquet Cardiovascular, LLC INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and b Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.