510(k) K142461 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
VASCU-GUARD Peripheral Vascular Patch
| Applicant | Synovis Life Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Nov 25, 2014 |
| Received | Sep 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2015 | Synovis Surgical Innovations, Inc. Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product cod Terminated |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.