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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device holder, heart-valve, prosthesis
Regulation Description Prosthetic heart valve holder.
Product CodeDTJ
Regulation Number 870.3935
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K813276  IONESCU-SHILEY VALVE HOLDER & HANDLE
  2.  K871596  IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)

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 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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