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510(k) K914385

OPTICAL VALVULOTOME by Intramed Laboratories, Inc. — Product Code MGZ

K914385 is an FDA 510(k) premarket notification submitted by Intramed Laboratories, Inc. for the device "OPTICAL VALVULOTOME". The FDA issued a decision of Substantially Equivalent on March 2, 1992. The device falls under product code MGZ (Valvulotome), a Class II device regulated under 21 CFR 870.4885. Intramed Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1992
Date Received
October 1, 1991
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)
  • K925283 — VALVULOTOME (February 10, 1994)
  • K934696 — ANGIOSCOPE (January 18, 1994)
  • K922114 — ENDOSCOPIC RETRIEVAL BASKET (August 3, 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

  • 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