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510(k) Data Aggregation

K Number

Device Name

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

Manufacturer

Aveera Medical, Inc.

Date Cleared

2025-07-03

(169 days)

Product Code

MGZ

Regulation Number

870.4885

Why did this record match?

Applicant Name (Manufacturer) :

Aveera Medical, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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