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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, ventricular, general & plastic surgery
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBS
Regulation Number 878.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SNYDER LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Component(s), broken 1
Difficult to remove 1
Balloon burst 1
Total Device Problems 4

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

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Oct-07-2010
2 Atrium Medical Corporation II Aug-14-2008
3 Concentric Medical Inc II Jan-12-2011

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