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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device detector, bubble, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass bubble detector.
Product CodeKRL
Regulation Number 870.4205
Device Class 2


Premarket Reviews
ManufacturerDecision
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SORIN
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Sensor problems 41
Device alarm system issue 2
False alarm 2
Break 2
Device damaged prior to use 2
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 50

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

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corp II Jan-24-2008
2 Terumo Cardiovascular Systems Corporation II Oct-08-2010

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