510(k) K241070 · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Gelsoft Plus Vascular Prostheses
| Applicant | Vascutek, Ltd., Renfrewshire, GB |
| Decision | Substantially Equivalent, Nov 15, 2024 |
| Received | Apr 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2026 | Vascutek, Ltd. Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, Open, Classified |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.