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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Delivered as unsterile product 3
Other (for use when an appropriate device code cannot be identified) 2
Tear, rip or hole in device packaging 1
Device operates differently than expected 1
No Known Device Problem 1
Failure to Adhere or Bond 1
Bent 1
Break 1
Fracture 1
Sterility 1
Total Device Problems 13

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

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Spine, Inc. II Oct-23-2013

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