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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
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
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 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device component 51
Incorrect measurement 25
Unsealed device packaging 23
Measurements, inaccurate 15
Incorrect or inadequate result 9
Foreign material present in device 9
Break 8
No Known Device Problem 6
Detachment of device or device component 5
Tear, rip or hole in device packaging 4
Contamination during use 4
Leak 3
No code available 2
High Readings 2
Component(s), broken 2
Particulates 2
Misassembled 2
Failure to reset 1
Failure to sense 1
Device inoperable 1
Device damaged prior to use 1
Air leak 1
Disconnection 1
Fluid leak 1
Difficult to flush 1
Foreign material 1
Defective item 1
Device disinfection or sterilization issue 1
Device misassembled during manufacturing or shipping 1
No Information 1
Total Device Problems 185

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