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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessory equipment, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass accessory equipment.
Product CodeKRI
Regulation Number 870.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 4
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 2
Total Device Problems 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 1 0 1 0 0
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc III Feb-26-2010
2 Terumo Cardiovascular Systems Corp II Oct-31-2014
3 Terumo Cardiovascular Systems Corporation II Oct-16-2012
4 Terumo Cardiovascular Systems Corporation II Sep-09-2011

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