• 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 Show TPLC since Back To Search Results
Device catheter, oximeter, fiber-optic
Regulation Description Fiberoptic oximeter catheter.
Product CodeDQE
Regulation Number 870.1230
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material Rupture 36
Leak / Splash 29
Incorrect, Inadequate or Imprecise Result or Readings 25
Adverse Event Without Identified Device or Use Problem 15
Appropriate Term/Code Not Available 8
Device Contamination with Chemical or Other Material 7
Output Problem 6
Difficult to Insert 5
Deflation Problem 5
Inflation Problem 3
Positioning Problem 3
Detachment Of Device Component 3
Kinked 3
Unable to Obtain Readings 3
Connection Problem 2
Difficult to Advance 2
Break 2
Shelf Life Exceeded 1
Material Twisted / Bent 1
Knotted 1
Looping 1
Incorrect Measurement 1
Peeled / Delaminated 1
Calibration Error 1
Torn Material 1
Positioning Failure 1
Fracture 1
Difficult To Position 1
Difficult to Remove 1
Defective Component 1
Human-Device Interface Problem 1
Burst Container or Vessel 1
Total Device Problems 172


-
-