510(k) K012098 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
PRECLUDE PERICARDIAL MEMBRANE
| Applicant | W. L. Gore & Associates, Inc., Elkton MD, US |
| Decision | Substantially Equivalent, Sep 20, 2001 |
| Received | Jul 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012098
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.