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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, umbilical artery
Regulation Description Intravascular catheter.
Product CodeFOS
Regulation Number 880.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K831988  INTRAVASCULAR CATHETER
  2.  K890685  BARD UMBILICAL VESSEL CATHETER
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 5
KLEIN-BAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Leak 205
Break 47
Crack 32
Device-device incompatibility 13
Fluid leak 12
Occlusion within device 8
Unknown (for use when the device problem is not known) 7
Component(s), broken 4
Migration of device or device component 4
Component incompatible 3
Material fragmentation 3
Material perforation 3
Device operates differently than expected 3
No Known Device Problem 3
Material deformation 2
Tears, rips, holes in device, device material 2
Defective item 2
Vacuum, loss of 2
Failure to zero 2
Blood in tubing 2
Other (for use when an appropriate device code cannot be identified) 2
Hole in material 2
Difficult to insert 2
Kinked 2
Inflation issue 1
Mechanical issue 1
Method, improper/incorrect 1
Detachment of device component 1
Air leak 1
Alarm, audible 1
Difficult to fold or unfold 1
Fracture 1
Pierce 1
Unable to obtain readings 1
Material separation 1
Device displays error message 1
Connection issue 1
Use of Device Issue 1
Cut in material 1
Structural problem 1
Split 1
Inadequate user interface 1
Infusion or flow issue 1
Total Device Problems 386

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