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U.S. Department of Health and Human Services

Product Classification

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Device balloon,detachable,for neurovascular occlusion
Regulation Description Neurovascular embolization device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeMZQ
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type 510(k)
Regulation Number 882.5950
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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