510(k) K963611 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
| Applicant | Vascutek, Ltd., Austin TX, US |
| Decision | Substantially Equivalent, Nov 21, 1996 |
| Received | Sep 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2021 | Vascutek, Ltd. The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches.
FSN says Tapered Carotid Patch 920875t Terminated |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.