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510(k) K912548

LEMAITRE-BOOKWALTER VESSEL DEVICES by Vascutech, Inc. — Product Code DWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1991
Date Received
June 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
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 DWP

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  • K183438 — Geomed Vascular Dilators (September 3, 2019)
  • K163524 — Vessel Dilator (June 29, 2017)
  • K130896 — VASCULAR PROBE, VASCULAR PROBE ES (April 24, 2013)
  • K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (August 31, 2010)
  • K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (July 12, 2003)
  • K960312 — RDI CARDIAC INSULATION PAD (April 19, 1996)
  • K911475 — LAPAROSCOPIC VESSEL ARTICULATOR (July 2, 1991)
  • K910682 — ROBICSEK PROBE/RETRACTOR (May 8, 1991)
  • K905159 — FLO-RESTER(R) VESSEL SIZER (February 7, 1991)