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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 26
Difficult to insert 21
Measurements, inaccurate 19
Deflation issue 18
Incorrect or inadequate result 16
No code available 15
Material frayed 14
Difficult to remove 13
Foreign material present in device 13
No Known Device Problem 12
Material rupture 10
Other (for use when an appropriate device code cannot be identified) 9
Unraveled material 9
Contamination during use 9
Fluid leak 8
Break 8
Inflation issue 7
Unknown (for use when the device problem is not known) 7
Incorrect measurement 6
Low readings 5
Difficult to advance 5
Positioning Issue 4
Unable to obtain readings 4
Cut in material 4
Device damaged prior to use 3
Tip breakage 3
High Readings 3
Connection issue 2
Balloon rupture 2
Sterility 2
Kinked 2
Output issue 2
Difficult to position 2
Stretched 2
Material perforation 2
Detachment of device component 2
Knotted 2
Air leak 2
Accuracy rate 1
Unintended movement 1
Sticking 1
Source, detachment from 1
Shelf life exceeded 1
Detachment of device or device component 1
Tubing, incorrect placement of 1
Erratic display 1
Failure to pace or properly pace 1
Disconnection 1
Fracture 1
Material twisted 1
Tears, rips, holes in device, device material 1
Uncoiled 1
Foreign material 1
Bent 1
Defective component 1
Failure to calibrate 1
Use of Device Issue 1
Melted 1
Twisting 1
Total Device Problems 314

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