K250105 is an FDA 510(k) clearance for the Boomerang Valvulotome (BMGVT080). This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by Aveera Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on July 3, 2025, 169 days after receiving the submission on January 15, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K250105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2025 |
| Decision Date | July 03, 2025 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MGZ - Valvulotome |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4885 |