510(k) K250105 ยท MGZ Valvulotome
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
| Applicant | Aveera Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Jul 3, 2025 |
| Received | Jan 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250105
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.