510(k) K233551 · 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, Dec 19, 2023 |
| Received | Nov 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233551
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2025 | W L Gore & Associates, Inc. GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, Open, Classified |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.