K250105

Substantially Equivalent

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

Applicant: Aveera Medical, Inc.
Product code: MGZ
Advisory panel: Cardiovascular
Date received: 2025-01-15
Decision date: 2025-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.