510(k) K131778 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
| Applicant | Maquet Cardiovascular, LLC, Wayne NJ, US |
| Decision | Substantially Equivalent, Nov 14, 2013 |
| Received | Jun 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131778
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2023 | Maquet Cardiovascular, LLC Fusion Bioline Vascular Graft, Part number M00201503046B0 Open, Classified |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.