510(k) K060396 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
IVENA VASCULAR PATCH
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, May 12, 2006 |
| Received | Feb 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060396
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.