510(k) K914447 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
GORE-TEX(R) VASCULAR GRAFTS, 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 K914447
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.