510(k) K260351
K260351 is an FDA 510(k) premarket notification submitted by MicroPort NeuroTech (Shanghai) Co., Ltd. for the device "Numen Helia Coil Embolization System; NumenFR Detachment System". The FDA issued a decision of Substantially Equivalent on May 20, 2026. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. MicroPort NeuroTech (Shanghai) Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2026
- Date Received
- February 3, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Neurovascular Embolization
- Device Class
- Class II
- Regulation Number
- 882.5950
- Review Panel
- NE
- Submission Type