Numen™ Helia Coil Embolization System; NumenFR™ Detachment System
Device Facts
| Record ID | K260351 |
|---|---|
| Device Name | Numen™ Helia Coil Embolization System; NumenFR™ Detachment System |
| Applicant | MicroPort NeuroTech (Shanghai) Co., Ltd. |
| Product Code | HCG · Neurology |
| Decision Date | May 20, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
