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510(k) K250105

Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) by Aveera Medical, Inc. — Product Code MGZ

K250105 is an FDA 510(k) premarket notification submitted by Aveera Medical, Inc. for the device "Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)". The FDA issued a decision of Substantially Equivalent on July 3, 2025. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
January 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valvulotome
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type

Other clearances for product code MGZ

  • K260188 — LimFlow Vector (March 18, 2026)
  • K221902 — LimFlow Vector (December 21, 2022)
  • K190267 — EZE SIT Valvulotome (October 30, 2019)
  • K142660 — Antegrade LeMills Valvulotome (October 17, 2014)
  • K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (April 10, 2014)
  • K132047 — LEMILLS VALVULOTOME (November 5, 2013)
  • K132190 — EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME (August 5, 2013)
  • K111884 — OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME (July 29, 2011)
  • K080178 — VALVULOTOME BY KOVEN (July 28, 2008)
  • K022823 — VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (July 1, 2004)

FDA data resources