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510(k) K260188

LimFlow Vector by LimFlow, Inc. — Product Code MGZ

K260188 is an FDA 510(k) premarket notification submitted by LimFlow, Inc. for the device "LimFlow Vector". The FDA issued a decision of Substantially Equivalent on March 18, 2026. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. LimFlow, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2026
Date Received
January 22, 2026
Clearance Type
Special
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 by LimFlow, Inc.

  • K251376 — LimFlow ARC (May 31, 2025)
  • K242776 — LimFlow V-Ceiver (February 14, 2025)
  • K221902 — LimFlow Vector (December 21, 2022)
  • K221541 — LimFlow ARC (August 31, 2022)
  • K222083 — LimFlow V-Ceiver (August 9, 2022)

Other clearances for product code MGZ

  • K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (July 3, 2025)
  • 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