510(k) K151865 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
PremiPatch PTFE Pledget
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Oct 27, 2015 |
| Received | Jul 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151865
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.