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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, hemodialysis, triple lumen, non-implanted
Regulation Description Blood access device and accessories.
Definition Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Product CodeNIE
Regulation Number 876.5540
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Hole in material 5
Kinked 2
Leak 2
Crack 2
Disconnection 1
Break 1
Device clogged 1
Detachment of device component 1
Material puncture 1
Material separation 1
Improper or incorrect procedure or method 1
Cut in material 1
Split 1
Human-Device Interface Issue 1
No Known Device Problem 1
Total Device Problems 22

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