• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
No code available 15
Material frayed 14
Difficult to remove 13
Incorrect or inadequate result 13
Foreign material present in device 13
No Known Device Problem 11
Unraveled material 9
Other (for use when an appropriate device code cannot be identified) 9
Contamination during use 9
Fluid leak 8
Break 8
Inflation issue 7
Material rupture 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
Cut in material 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
Material twisted 1
Detachment of device or device component 1
Tears, rips, holes in device, device material 1
Use of Device Issue 1
Defective component 1
Failure to calibrate 1
Unintended movement 1
Total Device Problems 307

-
-