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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device valvulotome
Regulation Description External vein stripper.
Product CodeMGZ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 5
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Instrumed International, Inc. II Dec-16-2014

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