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U.S. Department of Health and Human Services

Product Classification
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Device dural arteriovenous fistula liquid embolic
Definition Indicated for use in the treatment of intracranial dural arteriovenous fistulas.
Physical State Liquid
Technical Method Liquid embolic devices for treatment of dural arteriovenous fistulas are injected into the fistula and harden in place to stop blood flow.
Target Area Blood vessels on the dura of the brain.
Review Panel Neurology
Product CodeSGF
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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