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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
  1.  K043342  POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SI ...
  2.  K800336  GAMBRO LUNDIA FIBER
  3.  K801045  GF120H DIALYZER
  4.  K801370  GF-120-L DIALYZER
  5.  K820304  GAMBRO GF-80-M, GF-80-H HEMODIALYZER
  6.  K880083  GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS
  7.  K880084  GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS
  8.  K883589  GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
  9.  K890111  GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER
  10.  K892523  GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
  11.  K902481  GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 7
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Fluid leak 1526
No Known Device Problem 303
No Information 83
No code available 33
Crack 32
Other (for use when an appropriate device code cannot be identified) 24
Leak 23
Material rupture 15
Break 11
Patient-device incompatibility 9
Delamination 7
Material separation 5
Device Issue 5
Membrane leak(s) 4
Dent in material 2
Device handling issue 2
Filtration issue 2
Difficult to flush 2
Fracture 2
Burst 1
Infusion or flow issue 1
Ultrafiltration 1
Incompatibility problem 1
Material integrity issue 1
Use of Device Issue 1
Occlusion within device 1
Device damaged prior to use 1
Device disinfection or sterilization issue 1
Improper chemical reaction 1
Manufacturing or shipping issue associated with device 1
Loose or intermittent connection 1
Air leak 1
Material fragmentation 1
Hole in material 1
Foreign material present in device 1
Total Device Problems 2106

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Renal Therapies Group, LLC II Apr-05-2016

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