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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, urethral
Regulation Description Urological catheter and accessories.
Product CodeGBM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 4
Mushroomed 4
Peeled 2
Detachment of device or device component 2
Occlusion within device 2
Unsealed device packaging 1
Detachment of device component 1
Normal 1
Device disinfection or sterilization issue 1
Packaging issue 1
Torn material 1
Bent 1
Total Device Problems 21

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

Recalls
Manufacturer Recall Class Date Posted
1 Apogee Medical, Inc II Sep-21-2008
2 Coloplast Manufacturing US, LLC II Jun-03-2011

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