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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, neuro-vasculature, occluding balloon
Regulation Description Intravascular occluding catheter.
Definition Used to obstruct lower aortic blood flow to augment cerebral perfusion.
Product CodePAV
Regulation Number 882.5150
Device Class Humanitarian Device Exemption

Device Problems
No Known Device Problem 12
Total Device Problems 12

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 ZOLL Circulation, Inc. II Dec-03-2014

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