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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device apparatus, hemoperfusion, sorbent
Regulation Description Sorbent hemoperfusion system.
Product CodeFLD
Regulation Number 876.5870
Device Class 2


Premarket Reviews
ManufacturerDecision
ASAHI
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Loss of or failure to bond 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 1 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 Clark Research and Development Inc II Feb-28-2007
2 Gambro Renal Products, Incorporated II Aug-13-2014

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