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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system and accessories, isolated heart, transport and preservation
Regulation Description Isolated kidney perfusion and transport system and accessories.
Product CodeMSB
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
SANGSTAT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Vitrolife, Inc. II Jul-12-2011

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