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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 18
No code available 18
No Known Device Problem 15
Material frayed 14
Difficult to remove 13
Foreign material present in device 13
Material rupture 12
Contamination during use 9
Unraveled material 9
Other (for use when an appropriate device code cannot be identified) 9
Fluid leak 8
Break 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
Cut in material 4
Positioning Issue 4
Unable to obtain readings 4
Tip breakage 3
High Readings 3
Device damaged prior to use 3
Material perforation 2
Stretched 2
Connection issue 2
Output issue 2
Sterility 2
Kinked 2
Knotted 2
Difficult to position 2
Detachment of device component 2
Air leak 2
Balloon rupture 2
Bent 1
Disconnection 1
Erratic display 1
Melted 1
Failure to pace or properly pace 1
Foreign material 1
Fracture 1
Accuracy rate 1
Shelf life exceeded 1
Source, detachment from 1
Sticking 1
Tubing, incorrect placement of 1
Twisting 1
Uncoiled 1
Unintended movement 1
Detachment of device or device component 1
Material twisted 1
Tears, rips, holes in device, device material 1
Use of Device Issue 1
Defective component 1
Failure to calibrate 1
Total Device Problems 324

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