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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, ureteral, gastro-urology
Regulation Description Urological catheter and accessories.
Product CodeEYB
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT - KIT 1

Device Problems
Break 26
Material separation 7
Product quality issue 3
Material perforation 2
Cut in material 2
Material fragmentation 2
Misapplication 1
Unsealed device packaging 1
Detachment of device component 1
Deflation issue 1
Tears, rips, holes in device, device material 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Material deformation 1
Device Issue 1
Balloon leak(s) 1
Total Device Problems 52

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

Recalls
Manufacturer Recall Class Date Posted
1 Gyrus ACMI Corporation II Sep-16-2008

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