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510(k) K925283

VALVULOTOME by Intramed Laboratories, Inc. — Product Code MGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1994
Date Received
October 20, 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 Intramed Laboratories, Inc.

  • K953258 — TITANIUM HEMOSTATIC CLIP (January 5, 1996)
  • K942457 — GRAFT THROMBECTOMY INSTRUMENTS (February 7, 1995)
  • K931792 — ARTHROSCOPE (June 13, 1994)
  • K934696 — ANGIOSCOPE (January 18, 1994)
  • K922114 — ENDOSCOPIC RETRIEVAL BASKET (August 3, 1992)
  • K914385 — OPTICAL VALVULOTOME (March 2, 1992)
  • K904465 — FLEXIBLE ARTHROSCOPE (December 20, 1990)
  • K903528 — LAPAROSCOPE (September 4, 1990)
  • K902444 — CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (August 30, 1990)
  • K901010 — FLEXIBLE CHOLEDOCHOSCOPE (May 22, 1990)

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)