510(k) K122612 ยท MAL Graft, Vascular, Synthetic/Biologic Composite
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
| Applicant | Maquet Cardiovascular, LLC, Wayne NJ, US |
| Decision | Substantially Equivalent, Sep 10, 2012 |
| Received | Aug 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122612
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.