← Back to catalogue
Numen Coil Embolization System - Numen Coil Embolization System
FDA 510(k)Class II (US FDA 510(k))
510(k) K203625
Identifiers
- 510(k) Number
- K203625 FDA 510(k)
- FDA Product Code
- HCG FDA 510(k)
- Models / Variants
- Numen Coil Embolization System FDA 510(k)NumenFR Detachment System FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5950 FDA 510(k)
- Regulation Number
- 882.5950 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Numen Coil Embolization System - Numen Coil Embolization System by Microport Neurotech (shanghai) Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 2…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203625 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microport Neurotech (shanghai) Co., Ltd.
Sources (1)
- FDA 510(k) K203625 24 fields · synced Jun 18, 2026