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510(k) K992940

LEMAITRE BALLOON CATHETER WITH IRRIGATION by Vascutech, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2000
Date Received
August 31, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
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)
  • 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)
  • K932184 — STERILE LEMAITRE GLOW 'N TELL TAPE (July 22, 1993)

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