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510(k) K132190

EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME by LeMaitre Vascular, Inc. — Product Code MGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2013
Date Received
July 15, 2013
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 LeMaitre Vascular, Inc.

  • K212894 — PhasTIPP (March 31, 2022)
  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • K190267 — EZE SIT Valvulotome (October 30, 2019)
  • K183513 — XenoSure Dura Biologic Patch (June 13, 2019)
  • K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid (November 16, 2018)
  • K173323 — AnastoClip GC Closure System (March 8, 2018)
  • K152833 — Pruitt F3-S Polyurethane Carotid Shunt (January 21, 2016)
  • K143454 — Pruitt F3-S Carotid Shunt (August 27, 2015)
  • K142660 — Antegrade LeMills Valvulotome (October 17, 2014)
  • K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (April 10, 2014)

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)
  • 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)
  • K001734 — FOGARTY VALVULOTOME, MODEL 700091 (March 26, 2001)