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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, nephrostomy
Product CodeLJE
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 2
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 3
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 2
VPI
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material rupture 7
Detachment of device or device component 4
Torn material 4
Unsealed device packaging 3
Kinked 3
Balloon rupture 2
Bent 2
Break 2
Burst 2
Material separation 2
Other (for use when an appropriate device code cannot be identified) 2
Defective item 2
Foreign material present in device 1
No Known Device Problem 1
Unknown (for use when the device problem is not known) 1
Implant, removal of 1
Malfunction 1
Tears, rips, holes in device, device material 1
Difficult to position 1
Replace 1
Detachment of device component 1
Displacement 1
False reading from device non-compliance 1
Hole in material 1
Balloon asymmetrical 1
Incorrect measurement 1
Misapplication 1
Total Device Problems 50

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 1 0 0 0 0 0 1 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-09-2013
2 Boston Scientific Corporation II Jun-05-2007
3 Cook Inc. II Mar-24-2016

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