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510(k) K992941

LEMAITRE BILIARY CATHETER by Vascutech, Inc. — Product Code LQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2000
Date Received
August 31, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
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)
  • 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)
  • K932184 — STERILE LEMAITRE GLOW 'N TELL TAPE (July 22, 1993)

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