510(k) K001785 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
SURGISIS PERIPHERAL VASCULAR PATCH
| Applicant | Cook Biotech, Inc., West Lafayette IN, US |
| Decision | Substantially Equivalent, Dec 27, 2000 |
| Received | Jun 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2003 | Cook Biotech, Inc. Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10. Terminated |
DXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.