K250105
- 510(k) number
- K250105
- Device name
- Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
- Applicant
- Aveera Medical, Inc. CA · US
- Product code
- MGZ — Valvulotome
- Decision date
- 2025-07-03
- Date received
- 2025-01-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250105.pdf
Official FDA record: K250105
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.