510(k) K051405 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
REGENSIS PERICARDIAL PATCH
| Applicant | Cormatrix Cardiovascular, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 31, 2005 |
| Received | May 31, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051405
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.