Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)— 510(k) K250105

Name: FDA 510(k) clearance K250105
Creator: U.S. Food and Drug Administration
Published: 2025-07-03

Substantially Equivalent

Aveera Medical, Inc.

FDA 510(k) clearance K250105 for Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125), Substantially Equivalent on 2025-07-03. Applicant: Aveera Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aveera Medical, Inc.
Product code: Code MGZ
Device class: Class 2
Regulation: 21 CFR 870.4885
Advisory panel: Cardiovascular
Date received: 2025-01-15
Decision date: 2025-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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