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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dialyzer, capillary, hollow fiber
Regulation Description Hemodialysis system and accessories.
Product CodeFJI
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
ASAHI
  SUBSTANTIALLY EQUIVALENT 4
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 11
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 8
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 2
GAMBRO
  SUBSTANTIALLY EQUIVALENT 11
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 7
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Fluid leak 230
No code available 28
Other (for use when an appropriate device code cannot be identified) 24
No Known Device Problem 22
Leak 22
No Information 21
Patient-device incompatibility 9
Membrane leak(s) 4
Crack 2
Break 1
Use of Device Issue 1
Device disinfection or sterilization issue 1
Foreign material present in device 1
Incompatibility problem 1
Device handling issue 1
Air leak 1
Fracture 1
Total Device Problems 370

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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