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510(k) K221902

LimFlow Vector by LimFlow, Inc. — Product Code MGZ

K221902 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 December 21, 2022. 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
December 21, 2022
Date Received
June 30, 2022
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 by LimFlow, Inc.

  • K260188 — LimFlow Vector (March 18, 2026)
  • K251376 — LimFlow ARC (May 31, 2025)
  • K242776 — LimFlow V-Ceiver (February 14, 2025)
  • K221541 — LimFlow ARC (August 31, 2022)
  • K222083 — LimFlow V-Ceiver (August 9, 2022)

Other clearances for product code MGZ

  • K260188 — LimFlow Vector (March 18, 2026)
  • K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (July 3, 2025)
  • 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