510(k) K972201 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
| Applicant | Sulzer Carbomedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Apr 14, 1998 |
| Received | Jun 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972201
| 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.