510(k) K830806 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
| Applicant | W. L. Gore & Associates, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 13, 1983 |
| Received | Mar 14, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830806
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.