510(k) K231505 · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
GORE® ACUSEAL Vascular Graft
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Jun 23, 2023 |
| Received | May 24, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231505
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.