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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, tubing, blood, with and without anti-regurgitation valve
Regulation Description Hemodialysis system and accessories.
Product CodeFJK
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXELINT INTERNATIONAL CO
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 4
GAMBRO
  SUBSTANTIALLY EQUIVALENT 5
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISYSTEM
  SUBSTANTIALLY EQUIVALENT 2
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
NXSTAGE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Kinked 92
Material separation 91
Unknown (for use when the device problem is not known) 32
Leak 28
Fluid leak 16
Normal 12
Other (for use when an appropriate device code cannot be identified) 10
Disconnection 10
Cut in material 8
Not Applicable 8
Defective component 7
Overdelivery 6
Hole in material 6
Method, improper/incorrect 6
No Information 6
Use of Device Issue 5
Loss of or failure to bond 5
Loose or intermittent connection 4
No Known Device Problem 3
Source, detachment from 3
Air leak 3
Detachment of device component 3
Tip breakage 3
Crack 2
Break 2
Device damaged prior to use 2
Coagulation in device or device ingredient 2
Device alarm system issue 1
Restricted flowrate 1
Reaction 1
Material rupture 1
Component(s), broken 1
Connector pin failure 1
Filter 1
Tube(s), shattering of 1
Detachment of device or device component 1
No code available 1
Improper or incorrect procedure or method 1
Blockage within device or device component 1
Tube(s), defective 1
Dislocated 1
Unit inactivated 1
Device Issue 1
Infusion or flow issue 1
Total Device Problems 392

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

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. III May-07-2008
2 Fresenius Medical Care Holdings, Inc. I Jan-10-2011
3 Gambro Renal Products, Inc. II Sep-26-2008

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