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 a medical device manufactured by Aveera Medical, Inc.. It received FDA 510(k) clearance on 2025-07-03 under approval 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. It is manufactured by Aveera Medical, Inc.. The 510(k) number is K250105.
When was Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) approved by the FDA?
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) received FDA 510(k) clearance on 2025-07-03, under approval number K250105.
What company makes Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)?
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) is manufactured by Aveera Medical, Inc..
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 Devices (Code: MGZ)
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.