K260351
- 510(k) number
- K260351
- Device name
- Numen Helia Coil Embolization System; NumenFR Detachment System
- Applicant
- MicroPort NeuroTech (Shanghai) Co., Ltd. CN
- Product code
- HCG — Device, Neurovascular Embolization
- Decision date
- 2026-05-20
- Date received
- 2026-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K260351.pdf
Official FDA record: K260351
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.