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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, perfusion, kidney, disposable
Regulation Description Isolated kidney perfusion and transport system and accessories.
Product CodeKDL
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 2
Unknown (for use when the device problem is not known) 1
Device Issue 1
Total Device Problems 4

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 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Teva Pharmaceuticals USA, Inc. II Apr-18-2012

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