510(k) K252445 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Fusion Bioline Vascular Graft
| Applicant | Maquet Cardiovascular, LLC, Wayne NJ, US |
| Decision | Substantially Equivalent, Apr 27, 2026 |
| Received | Aug 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252445
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.