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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, suprapubic (and accessories)
Regulation Description Suprapubic urological catheter and accessories.
Product CodeKOB
Regulation Number 876.5090
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
FEMICARE-NIKOMED LTD
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material separation 5
Leak 3
Tip breakage 3
Balloon rupture 3
Balloon burst 3
Device, or device fragments remain in patient 2
Break 2
Detachment of device or device component 1
Device damaged prior to use 1
Difficult to advance 1
Device, removal of (non-implant) 1
Device Issue 1
Device clogged 1
Calcified 1
Inflation issue 1
Tear, rip or hole in device packaging 1
Deflation issue 1
Unknown (for use when the device problem is not known) 1
Occlusion within device 1
Total Device Problems 33

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 0
Class III 0 0 0 0 0 0 0 0 0 0


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