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510(k) K932184

STERILE LEMAITRE GLOW 'N TELL TAPE by Vascutech, Inc. — Product Code KFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
May 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Device Class
Class II
Regulation Number
890.3500
Review Panel
PM
Submission Type

Other clearances by Vascutech, Inc.

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  • 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)
  • K932009 — THE SAMUELS RETROGRAD VALVULOTOME (September 21, 1993)

Other clearances for product code KFX

  • K833868 — IPOS G.L.P. SYSTEM (November 28, 1983)
  • K830285 — REGNELL HYDRAULIC FEMORAL PROTHESIS (March 9, 1983)
  • K822240 — ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (December 30, 1982)