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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heat-exchanger, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass heat exchanger.
Product CodeDTR
Regulation Number 870.4240
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
COBE INC.
  SUBSTANTIALLY EQUIVALENT 3
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 10
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINNTECH
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCIMED
  SUBSTANTIALLY EQUIVALENT 4
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 11
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 73
Fluid leak 50
Other (for use when an appropriate device code cannot be identified) 21
Device displays error message 12
Blockage within device or device component 10
Air leak 6
Nonstandard device or device component 6
Device Issue 5
Device operates differently than expected 5
Flare or flash 5
Failure to prime 5
Component missing 4
Manufacturing or shipping issue associated with device 3
Foreign material present in device 2
Infusion or flow issue 2
Crack 2
Burst 2
Defective item 2
Insufficient cooling 1
Failure to Adhere or Bond 1
Foreign material 1
Hole in material 1
Excess flow or overinfusion 1
Incorrect display 1
Migration of device or device component 1
Pumping stopped 1
Difficult to remove 1
Self-activation or keying 1
Sticking 1
Difficult to open or close 1
No flow 1
Output issue 1
Pressure issue 1
Not Applicable 1
Failure to deliver 1
Tear, rip or hole in device packaging 1
Split 1
Occlusion within device 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 236

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 2 0 0 0 2 1 0
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Mar-10-2014
2 Quest Medical, Inc III Apr-08-2011
3 Quest Medical, Inc. II Dec-02-2015
4 Terumo Cardiovascular Corporation II Sep-29-2010
5 Terumo Cardiovascular Systems Corp II Oct-31-2014
6 Terumo Cardiovascular Systems Corp II Aug-02-2010

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