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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device filter, blood, cardiopulmonary bypass, arterial line
Regulation Description Cardiopulmonary bypass arterial line blood filter.
Product CodeDTM
Regulation Number 870.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COBE INC.
  SUBSTANTIALLY EQUIVALENT 3
DIDECO
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 10
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 3
SORIN
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 9
  1.  K002026  CAPIOX ARTERIAL FILTER
  2.  K011804  CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT COD ...
  3.  K032128  TERUMO AL8X ARTERIAL FILTER WITH X-COATING
  4.  K052205  CAPIOX AF125X ARTERIAL FILTER
  5.  K083747  TERUMO PALL AL3X ARTERIAL FILTER
  6.  K083834  TERUMO PALL AL6X ARTERIAL FILTER
  7.  K121209  TERUMO PALL AL20X ARTERIAL FILTER
  8.  K812659  TERUMO HOLLOW OXYGENATOR CIRCUIT
  9.  K943917  CAPIOX ARTERIAL FILTER

Device Problems
Leak 28
Fluid leak 27
Other (for use when an appropriate device code cannot be identified) 7
Particulates 6
Filter break(s) 4
Infusion or flow issue 3
Filtration issue 2
Pressure issue 2
Increase in pressure 2
Material separation 2
Device damaged prior to use 2
Crack 2
Blockage within device or device component 2
Break 1
Burst 1
Component(s), broken 1
Detachment of device component 1
Filter leak(s) 1
Fracture 1
Dislodged or dislocated 1
Occlusion within device 1
Use of Device Issue 1
Device handling issue 1
Free or unrestricted flow 1
No Known Device Problem 1
Total Device Problems 101

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

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-14-2013
2 Medtronic Perfusion Systems II Jul-24-2008
3 Terumo Cardiovascular Systems Corporation II Sep-20-2013

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