510(k) K172660 ยท PSQ Intracardiac Patch Or Pledget, Biologically Derived
Duravess bovine pericardial vascular patch
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 17, 2017 |
| Received | Sep 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172660
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.