510(k) K013250 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Oct 26, 2001 |
| Received | Sep 28, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013250
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.