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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device occluder, catheter tip
Regulation Description Catheter tip occluder.
Product CodeDQT
Regulation Number 870.1370
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device, or device fragments remain in patient 5
Wire(s), breakage of 4
Stretched 3
Tip breakage 2
Dissection 1
Material fragmentation 1
Total Device Problems 16

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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