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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, oximeter, fiberoptic
Regulation Description Fiberoptic oximeter catheter.
Product CodeDQE
Regulation Number 870.1230
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 5
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 28
Incorrect or inadequate result 24
Difficult to insert 21
Measurements, inaccurate 19
Deflation issue 18
No Known Device Problem 18
No code available 18
Material rupture 15
Material frayed 14
Difficult to remove 13
Foreign material present in device 13
Unraveled material 9
Other (for use when an appropriate device code cannot be identified) 9
Contamination during use 9
Break 8
Fluid leak 8
Inflation issue 7
Unknown (for use when the device problem is not known) 7
Output issue 6
Incorrect measurement 6
Difficult to advance 5
Low readings 5
Cut in material 4
Positioning Issue 4
Unable to obtain readings 4
Detachment of device component 4
Knotted 3
High Readings 3
Device damaged prior to use 3
Tip breakage 3
Stretched 2
Material perforation 2
Connection issue 2
Sterility 2
Difficult to position 2
Air leak 2
Balloon rupture 2
Kinked 2
Foreign material 1
Fracture 1
Disconnection 1
Erratic display 1
Bent 1
Burst 1
Accuracy rate 1
Looping 1
Melted 1
Failure to pace or properly pace 1
Peeled 1
Sticking 1
Shelf life exceeded 1
Source, detachment from 1
Detachment of device or device component 1
Defective component 1
Failure to calibrate 1
Tears, rips, holes in device, device material 1
Use of Device Issue 1
Tubing, incorrect placement of 1
Twisting 1
Uncoiled 1
Unintended movement 1
Material twisted 1
Total Device Problems 348

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