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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device controller, infusion, intravascular, electronic
Regulation Description Infusion pump.
Product CodeLDR
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
DEKA RESEARCH & DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 2
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
LEVENTON, S.A.
  SUBSTANTIALLY EQUIVALENT 1
M.C. JOHNSON CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
MILLIPORE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRIMEDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 1

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 1 2 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ConMed Corporation II Jan-11-2012
2 ConMed Corporation II Jan-11-2012
3 Leventon S. A. U. II Jun-21-2011

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