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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device valvulotome
Regulation Description External vein stripper.
Product CodeMGZ
Regulation Number 870.4885
Device Class 2


Premarket Reviews
ManufacturerDecision
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Difficult to Open or Close 27
Failure to Align 13
Sticking 4
Material Deformation 2
Bent 1
Material Separation 1
Failure to Cut 1
Insufficient Information 1
Device Operates Differently Than Expected 1
Difficult to Open or Remove Packaging Material 1
Difficult to Remove 1
Total Device Problems 53

Recalls
Manufacturer Recall Class Date Posted
1 LeMaitre Vascular, Inc. II Aug-16-2016

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