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510(k) K924075

DISPOSABLE OPTICAL VALVULOTOME by Endovascular, Inc. — Product Code MGZ

K924075 is an FDA 510(k) premarket notification submitted by Endovascular, Inc. for the device "DISPOSABLE OPTICAL VALVULOTOME". The FDA issued a decision of Substantially Equivalent on February 8, 1993. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. Endovascular, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1993
Date Received
August 12, 1992
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 Endovascular, Inc.

  • K931421 — DISPOSABLE STEERABLE ANGIOSCOPE (June 16, 1993)
  • K923996 — DISPOSABLE VASCULAR ANGIOSCOPE (January 13, 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