510(k) K955230 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
| Applicant | Vascutek, Ltd., Austin TX, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Feb 9, 1996 |
| Received | Nov 14, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955230
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2021 | Vascutek, Ltd. The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular graft Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.