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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, subclavian
Regulation Description Blood access device and accessories.
Product CodeLFJ
Regulation Number 876.5540
Device Class 3


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT WITH DRUG 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - KIT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 7
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 23
Crack 21
Break 8
Volume accuracy issue 8
Unraveled material 7
Occlusion within device 6
Hole in material 6
No flow 4
Component(s), broken 3
Fracture 3
Fluid leak 2
Material separation 2
Device, or device fragments remain in patient 2
Difficult to remove 2
No Known Device Problem 2
Other (for use when an appropriate device code cannot be identified) 2
Device, removal of (non-implant) 2
Detachment of device or device component 1
Device-device incompatibility 1
Mechanical jam 1
Unknown (for use when the device problem is not known) 1
Failure to disconnect 1
Torn material 1
No Information 1
Material rupture 1
Stretched 1
Kinked 1
Decoupling 1
Detachment of device component 1
Device clogged 1
Total Device Problems 116

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