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U.S. Department of Health and Human Services

Product Classification

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Device device, neurovascular embolization
Regulation Description Neurovascular embolization device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHCG
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurointerventional Devices Branch (NIDB)
Submission Type 510(k)
Regulation Number 882.5950
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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