510(k) K082139 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 23, 2008 |
| Received | Jul 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082139
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.