510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250105Substantially Equivalent

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

Aveera Medical, San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250105 is the FDA 510(k) clearance record for Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125), a class II device, cleared for Aveera Medical, Inc. on under FDA product code MGZ (Valvulotome). FDA records list one 510(k) clearance for Aveera Medical, Inc. As of , FDA records show no recalls naming K250105.

Clearance record

Decision date
Received
(169 days to decision)
Product code
MGZ Valvulotome
Regulation
21 CFR 870.4885
Device class
Class II
Review panel
Cardiovascular
Applicant
Aveera Medical, Inc. 929 Calle Negocio, San Clemente CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MGZ

Trailing 12 months
1 clearance under product code MGZ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MGZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260