Numen Helia
Numen Helia is a detachable coil embolization system used to obstruct blood flow in neurovascular and peripheral vascular abnormalities. The coil is a permanent implant delivered through a…
Numen Helia is a detachable coil embolization system used to obstruct blood flow in neurovascular and peripheral vascular abnormalities. The coil is a permanent implant delivered through a microcatheter to the target region.
The delivery assembly includes an introducer sheath and a coil system made up of a pusher and the implant. The sheath helps introduce the coil into the microcatheter, and the pusher advances it through that delivery path.
Detachment Equipment
The coil system works with a separately supplied NumenFR detachment unit. This sterile handheld unit is battery powered and intended for one patient; it performs the release function while the coil remains as the implanted part.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Microport Neurotech (Shanghai) Co., Ltd., China |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| Establishment | Manufacturer |
| 510(k) | K260351 |
| Record published | 2026-07-15 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3D0340SS | In distribution | |
| 1D0360SS | In distribution | |
| 3D1H08SS | In distribution | |
| 1D1H06SS | In distribution | |
| 1D3H35SS | In distribution | |
| 3D0304SS | In distribution | |
| 3D2H04SS | In distribution | |
| 1D3H08SS | In distribution | |
| 1D0350SS | In distribution | |
| 1D3H30SS | In distribution | |
| 1D1H15SS | In distribution | |
| 1D1H08SS | In distribution | |
| 3D2H40SS | In distribution | |
| 1D0210SS | In distribution | |
| 3D2H20SS | In distribution | |
| 1D0230SS | In distribution | |
| 1D0250SS | In distribution | |
| 3D0208SS | In distribution | |
| 3D3H20SS | In distribution | |
| 3D0330SS | In distribution | |
| 3D3H15SS | In distribution | |
| 1D0315SS | In distribution | |
| 3D3H06SS | In distribution | |
| 3D3H40SS | In distribution | |
| 1D0335SS | In distribution | |
| 1D0325SS | In distribution | |
| 1D1H20SS | In distribution | |
| 3D0204SS | In distribution | |
| 1D3H25SS | In distribution | |
| 1D1H03SS | In distribution | |
| 1D2H10SS | In distribution | |
| 3D0335SS | In distribution | |
| 3D0310SS | In distribution | |
| 3D1H06SS | In distribution | |
| 1D3H04SS | In distribution | |
| 1D0320SS | In distribution | |
| 1D0340SS | In distribution | |
| 3D0203SS | In distribution | |
| 3D0235SS | In distribution | |
| 1D2H40SS | In distribution | |
| 3D0220SS | In distribution | |
| 1D0330SS | In distribution | |
| 1D0206SS | In distribution | |
| 1D1H10SS | In distribution | |
| 3D0202SS | In distribution | |
| 1D3H40SS | In distribution | |
| 1D0306SS | In distribution | |
| 1D0304SS | In distribution | |
| 3D0240SS | In distribution | |
| 3D3H10SS | In distribution | |
| 3D0110SS | In distribution | |
| 3D2H06SS | In distribution | |
| 3D3H08SS | In distribution | |
| 3D0320SS | In distribution | |
| 3D0308SS | In distribution | |
| 3D0325SS | In distribution | |
| 1D0208SS | In distribution | |
| 3D3H04SS | In distribution | |
| 1D3H15SS | In distribution | |
| 1D3H06SS | In distribution | |
| 1D2H15SS | In distribution | |
| 3D1H20SS | In distribution | |
| 3D1H15SS | In distribution | |
| 1D0245SS | In distribution | |
| 3D1H04SS | In distribution | |
| 3D3H60SS | In distribution | |
| 1D0240SS | In distribution | |
| 3D0360SS | In distribution | |
| 3D0230SS | In distribution | |
| 3D2H50SS | In distribution | |
| 1D2H06SS | In distribution | |
| 1D3H10SS | In distribution | |
| 1D0215SS | In distribution | |
| 1D0235SS | In distribution | |
| 1D0106SS | In distribution | |
| 3D0120SS | In distribution | |
| 3D2H08SS | In distribution | |
| 1D2H04SS | In distribution | |
| 3D3H50SS | In distribution | |
| 1D2H35SS | In distribution | |
| 3D3H25SS | In distribution | |
| 1D0104SS | In distribution | |
| 1D0120SS | In distribution | |
| 1D0108SS | In distribution | |
| 3D1H03SS | In distribution | |
| 1D0308SS | In distribution | |
| 3D0215SS | In distribution | |
| 3D3H30SS | In distribution | |
| 1D2H20SS | In distribution | |
| 3D0115SS | In distribution | |
| 3D2H45SS | In distribution | |
| 1D1H04SS | In distribution | |
| 3D2H30SS | In distribution | |
| 1D0220SS | In distribution | |
| 3D0250SS | In distribution | |
| 1D2H50SS | In distribution | |
| 3D0350SS | In distribution | |
| 3D1H10SS | In distribution | |
| 3D2H15SS | In distribution | |
| 1D2H08SS | In distribution | |
| 3D3H35SS | In distribution | |
| 1D0115SS | In distribution | |
| 3D1H02SS | In distribution | |
| 3D0206SS | In distribution | |
| 1D3H50SS | In distribution | |
| 3D0104SS | In distribution | |
| 3D0106SS | In distribution | |
| 3D0210SS | In distribution | |
| 1D3H60SS | In distribution | |
| 1D1H02SS | In distribution | |
| 1D0103SS | In distribution | |
| 1D0102SS | In distribution | |
| 1D2H30SS | In distribution | |
| 1D0203SS | In distribution | |
| 1D0310SS | In distribution | |
| 3D0108SS | In distribution | |
| 1D2H45SS | In distribution | |
| 3D2H35SS | In distribution | |
| 1D3H20SS | In distribution | |
| 1D0110SS | In distribution | |
| 3D0315SS | In distribution | |
| 3D2H03SS | In distribution | |
| 3D2H10SS | In distribution | |
| 1D2H03SS | In distribution | |
| 1D0202SS | In distribution | |
| 3D0306SS | In distribution | |
| 3D0103SS | In distribution | |
| 3D0102SS | In distribution | |
| 1D0204SS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| Smart Coil | Penumbra Inc. | 238 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 234 |
| Numen | Microport Neurotech (Shanghai) Co., Ltd. | 223 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Barricade Coil System | Balt USA, LLC | 137 |
| V-Trak | MicroVention, Inc. | 106 |
| HydroSoft Helical | MicroVention, Inc. | 94 |
| AxiumTM | Micro Therapeutics, Inc. | 89 |
| LP Coil System | Penumbra Inc. | 77 |
| Trufill DCS Orbit | Cerenovus, Inc. | 74 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260351 | 2026-05-20 |
| K242154 | 2024-09-30 |
| K232955 | 2024-01-10 |
| K203625 | 2021-09-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.