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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stripper, vein, external
Regulation Description External vein stripper.
Product CodeDWQ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Difficult to remove 1
Total Device Problems 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 0 0 0
Class III 1 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. III Mar-18-2015
2 Smith & Nephew, Inc Endoscopy Division III Aug-02-2007

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