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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
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 92
Incorrect or inadequate result 77
Incorrect measurement 29
Unsealed device packaging 26
Foreign material present in device 21
Break 18
Fracture 16
Particulates 16
Measurements, inaccurate 15
No Known Device Problem 14
Detachment of device or device component 13
Device handling issue 10
No code available 7
Leak 6
Tear, rip or hole in device packaging 5
Contamination during use 5
Material fragmentation 5
Entrapment of device or device component 5
Kinked 4
Device alarm system issue 2
Incorrect display 2
Difficult to position 2
Increase in pressure 2
Difficult to remove 2
Incorrect or inadequate test results 2
High Readings 2
Component(s), broken 2
Positioning Issue 2
No Information 2
Device operates differently than expected 2
Misassembled 2
Device disinfection or sterilization issue 1
Device misassembled during manufacturing or shipping 1
Failure to sense 1
Sticking 1
Device inoperable 1
Use of Device Issue 1
Device damaged prior to use 1
Defective component 1
Device packaging compromised 1
Material deformation 1
Air leak 1
Crack 1
Disconnection 1
Fire 1
Fluid leak 1
Difficult to flush 1
Foreign material 1
Hole in material 1
Excess flow or overinfusion 1
Failure to advance 1
Physical resistance 1
Defective item 1
Calibration issue 1
Delamination 1
Failure to reset 1
Total Device Problems 433

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 2 0 0
Class III 0 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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