510(k) K013022 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
| Applicant | Sulzer Carbomedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jun 13, 2002 |
| Received | Sep 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013022
| 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.