📋 FDA Reference

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

MicroPort NeuroTech (Shanghai) Co., Ltd.

FDA Clearance Information

Pathway 510K
Decision Date May 20, 2026
Product Code HCG
Device Class Class 2
Evidence 0 studies
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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