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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, ventricular (containing antibiotic or antimicrobial agents)
Regulation Description Ventricular catheter.
Definition Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Product CodeNHC
Regulation Number 882.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Fracture 1
Material separation 1
Tip breakage 1
Other (for use when an appropriate device code cannot be identified) 1
No Known Device Problem 1
Total Device Problems 5

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

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Dec-14-2015

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