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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, pressure, catheter tip
Regulation Description Catheter tip pressure transducer.
Product CodeDXO
Regulation Number 870.2870
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 7
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  1.  K880830  SENTORR ARTERIAL PRESSURE SENSOR
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 64
Incorrect measurement 26
Unsealed device packaging 25
Incorrect or inadequate result 21
Measurements, inaccurate 15
Break 13
Foreign material present in device 11
Particulates 10
Device handling issue 9
Detachment of device or device component 8
No Known Device Problem 8
No code available 6
Contamination during use 5
Tear, rip or hole in device packaging 5
Leak 3
Component(s), broken 2
Incorrect display 2
Device alarm system issue 2
Difficult to remove 2
Misassembled 2
Increase in pressure 2
High Readings 2
Failure to reset 1
Difficult to flush 1
Delamination 1
Failure to sense 1
Physical resistance 1
Device operates differently than expected 1
Foreign material 1
Fracture 1
Device inoperable 1
Defective component 1
Disconnection 1
Entrapment of device or device component 1
Device damaged prior to use 1
Device disinfection or sterilization issue 1
Fluid leak 1
Difficult to position 1
Crack 1
No Information 1
Incorrect or inadequate test results 1
Defective item 1
Sticking 1
Device misassembled during manufacturing or shipping 1
Device packaging compromised 1
Air leak 1
Material fragmentation 1
Hole in material 1
Total Device Problems 269

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

Recalls
Manufacturer Recall Class Date Posted
1 Edward Lifesciences, Llc II Sep-16-2015
2 Edwards Lifesciences, LLC II Dec-17-2015

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