510(k) K914448 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Nov 5, 1991 |
| Received | Oct 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914448
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.