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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, infusion
Regulation Description Introduction/drainage catheter and accessories.
Product CodeJCY
Regulation Number 878.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Bubble(s) 1
Leak 1
No Information 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 0 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 Linvatec Corp. dba ConMed Linvatec II Mar-25-2011
2 Medical Device Technologies, Inc. II Jul-13-2010

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