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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe, thermodilution
Regulation Description Thermodilution probe.
Product CodeKRB
Regulation Number 870.1915
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
ELECATH
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PULSION MEDICAL INC., USA
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Deflation issue 10
Measurements, inaccurate 7
Break 3
Incorrect measurement 3
Inflation issue 2
Balloon rupture 1
Design/structure problem 1
False reading from device non-compliance 1
Material fragmentation 1
Material frayed 1
Tears, rips, holes in device, device material 1
Component missing 1
Cut in material 1
Low readings 1
No Known Device Problem 1
Total Device Problems 35

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