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FDA 510(k)

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

K-Number: K250105 · 2025-07-03

ApplicantAveera Medical, Inc.
Decision Date2025-07-03
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) is the device name listed in this FDA 510(k) record. The listed applicant is Aveera Medical, Inc.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K250105. The device is classified under product code MGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)?

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Aveera Medical, Inc.. The 510(k) number is K250105.

When did Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) receive FDA 510(k) clearance?

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) received FDA 510(k) clearance on 2025-07-03, under 510(k) number K250105.

Who is the listed applicant for Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)?

The FDA 510(k) record lists Aveera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)?

The FDA product code for Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) is MGZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06311773Pivotal Trial of the Boomerang Catheter for pDVAENROLLING_BY_INVITATION

Related Devices (Code: MGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260188LimFlow VectorLimFlow, Inc.K221902LimFlow VectorLimFlow, Inc.K190267EZE SIT ValvulotomeLemaitre Vascular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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