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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State A multi-lumen catheter with two balloons mounted near the distal tip
Technical Method Temporary balloon inflation in the descending aortic artery obstructs or redirect blood flow
Target Area Double balloon catheter deployed in the descending aortic artery and hypothesized to increase cerebral blood flow
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePAV
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type HDE - Humanitarian Device Exemption
Regulation Number 882.5150
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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