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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
Incorrect or inadequate result 22
Difficult to insert 21
Measurements, inaccurate 19
Deflation issue 18
No code available 18
No Known Device Problem 17
Material frayed 14
Material rupture 14
Foreign material present in device 13
Difficult to remove 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
Incorrect measurement 6
Difficult to advance 5
Low readings 5
Output issue 5
Positioning Issue 4
Cut in material 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
Material perforation 2
Connection issue 2
Difficult to position 2
Sterility 2
Stretched 2
Air leak 2
Balloon rupture 2
Kinked 2
Foreign material 1
Fracture 1
Disconnection 1
Erratic display 1
Bent 1
Burst 1
Tears, rips, holes in device, device material 1
Sticking 1
Shelf life exceeded 1
Source, detachment from 1
Accuracy rate 1
Melted 1
Failure to pace or properly pace 1
Looping 1
Detachment of device or device component 1
Defective component 1
Failure to calibrate 1
Use of Device Issue 1
Tubing, incorrect placement of 1
Twisting 1
Uncoiled 1
Unintended movement 1
Material twisted 1
Total Device Problems 340

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