510(k) K984526 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
ACUSEAL CARDIOVASCULAR PATCH
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Apr 8, 1999 |
| Received | Dec 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984526
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.