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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 3
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 5
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Difficult to insert 21
Measurements, inaccurate 19
Deflation issue 17
Leak 16
Material frayed 14
No code available 14
Difficult to remove 12
Incorrect or inadequate result 10
Foreign material present in device 10
No Known Device Problem 9
Unraveled material 9
Other (for use when an appropriate device code cannot be identified) 9
Contamination during use 9
Fluid leak 8
Inflation issue 7
Break 7
Unknown (for use when the device problem is not known) 7
Incorrect measurement 6
Material rupture 6
Low readings 5
Cut in material 4
Difficult to advance 4
Unable to obtain readings 4
Tip breakage 3
High Readings 3
Positioning Issue 3
Device damaged prior to use 3
Material perforation 2
Stretched 2
Output issue 2
Connection issue 2
Sterility 2
Kinked 2
Knotted 2
Difficult to position 2
Air leak 2
Balloon rupture 2
Bent 1
Detachment of device component 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
Detachment of device or device component 1
Unintended movement 1
Tears, rips, holes in device, device material 1
Use of Device Issue 1
Defective component 1
Failure to calibrate 1
Total Device Problems 280

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