Cleared Traditional

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)

K250105 · Aveera Medical, Inc. · Cardiovascular

Jul 2025

Decision

169d

Days

Class 2

Risk

About This 510(k) Submission

K250105 is an FDA 510(k) clearance for the Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125), 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 review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number	K250105 FDA.gov
FDA Decision	Cleared 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