510(k) K034010 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
GELSOFT PLUS ERS
| Applicant | Vascutek, Ltd., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Feb 19, 2004 |
| Received | Dec 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034010
| 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.