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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
Adverse Event Without Identified Device or Use Problem 12
Total Device Problems 12


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