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510(k) K932009

THE SAMUELS RETROGRAD VALVULOTOME by Vascutech, Inc. — Product Code MGZ

K932009 is an FDA 510(k) premarket notification submitted by Vascutech, Inc. for the device "THE SAMUELS RETROGRAD VALVULOTOME". The FDA issued a decision of Substantially Equivalent on September 21, 1993. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. Vascutech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1993
Date Received
April 23, 1993
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 Vascutech, Inc.

  • K001621 — DARDIK CAROTID SHUNT (December 6, 2000)
  • K992942 — LEMAITRE OCCLUSION CATHETER (April 13, 2000)
  • K992933 — LEMAITRE IRRIGATION CATHETER (March 8, 2000)
  • K992934 — LEMAITRE VENOUS THROMBECTOMY CATHETER (March 1, 2000)
  • K992940 — LEMAITRE BALLOON CATHETER WITH IRRIGATION (February 22, 2000)
  • K992941 — LEMAITRE BILIARY CATHETER (January 12, 2000)
  • K992368 — LEMAITRE EMBOLECTOMY CATHETER (December 9, 1999)
  • K980723 — 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) (February 12, 1999)
  • K946352 — LEMAITRE VALVULOTOME II (June 21, 1995)
  • K932184 — STERILE LEMAITRE GLOW 'N TELL TAPE (July 22, 1993)

Other clearances for product code MGZ

  • K260188 — LimFlow Vector (March 18, 2026)
  • 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)

FDA data resources