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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sucker, cardiotomy return, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass cardiotomy return sucker.
Product CodeDTS
Regulation Number 870.4420
Device Class 2


Premarket Reviews
ManufacturerDecision
California Medical Laboratories Inc
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL BIOPHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Oversensing 34
Dislodged or dislocated 21
High capture threshold 14
Low impedance 11
Failure to capture 9
High impedance 8
Failure to sense 5
Device sensing issue 5
Device operates differently than expected 4
No Known Device Problem 4
Decreased sensitivity 3
Sensing intermittently 3
Difficult to remove 3
Break 3
Retraction problem 2
Capturing issue 2
Undersensing 2
Failure to advance 2
Difficult to advance 2
Foreign material present in device 1
Unraveled material 1
Low sensing threshold 1
Mechanical issue 1
Occlusion within device 1
Intermittent capture 1
Detachment of device component 1
Material fragmentation 1
Total Device Problems 145

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

Recalls
Manufacturer Recall Class Date Posted
1 California Medical Laboratories Inc II Jan-07-2013
2 California Medical Laboratories Inc II Jun-11-2008
3 International Biophysics Corp II Nov-23-2011
4 International Biophysics Corp. II Aug-19-2015
5 Terumo Cardiovascular Systems Corporation II Oct-17-2011
6 Terumo Cardiovascular Systems Corporation II Aug-04-2009

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