Numen
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities…
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
5manufacturers in China registered for this device type
223catalogue numbers in this listing
4510(k) clearances naming this product code
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) | K203625 |
| Record published | 2022-03-15 |
| Record revised | 2024-11-05 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3D2470FR | In distribution | |
| 3D0304FN | In distribution | |
| 1D1640HL | In distribution | |
| 3D0520FN | In distribution | |
| 1D3H06HL | In distribution | |
| 3D0615FNM2 | In distribution | |
| 3D0610FNM2 | In distribution | |
| 3D4H08FN | In distribution | |
| 3D0520FNM2 | In distribution | |
| 3D1132FR | In distribution | |
| 1D0830HL | In distribution | |
| 3D0410FR | In distribution | |
| 3D0835FR | In distribution | |
| 1D1240HL | In distribution | |
| 3D0718FN | In distribution | |
| 3D1332FR | In distribution | |
| 3D1H02FN | In distribution | |
| 3D1435FR | In distribution | |
| 3D0310FN | In distribution | |
| 3D0102FN | In distribution | |
| 3D0826FN | In distribution | |
| 1D0208HL | In distribution | |
| 3D0306FN | In distribution | |
| 3D0415FNM2 | In distribution | |
| 3D0718FNM2 | In distribution | |
| 3D0306FNM2 | In distribution | |
| 1D0203HL | In distribution | |
| 3D4H10FNM2 | In distribution | |
| 3D2058FR | In distribution | |
| 3D1026FR | In distribution | |
| 3D4H14FN | In distribution | |
| 1D0102HL | In distribution | |
| 1D0840HL | In distribution | |
| 3D3H08FN | In distribution | |
| 3D0712FNM2 | In distribution | |
| 3D1H02FNM2 | In distribution | |
| 3D0620FN | In distribution | |
| 3D0820FR | In distribution | |
| 3D0508FN | In distribution | |
| 1D1650HL | In distribution | |
| 3D4H10FN | In distribution | |
| 1D2040HL | In distribution | |
| 3D0408FN | In distribution | |
| 3D0835FNM2 | In distribution | |
| 3D0520FR | In distribution | |
| 3D0515FR | In distribution | |
| 3D0615FR | In distribution | |
| 3D1337FR | In distribution | |
| 3D4H08FR | In distribution | |
| 3D0620FNM2 | In distribution | |
| 1D1045HL | In distribution | |
| 3D0204FN | In distribution | |
| 1D0506HL | In distribution | |
| 1D2055HL | In distribution | |
| 3D0835FN | In distribution | |
| 3D0406FR | In distribution | |
| 3D1851FR | In distribution | |
| 3D1H04FN | In distribution | |
| 1D0715HL | In distribution | |
| 1D0101HL | In distribution | |
| 1D1250HL | In distribution | |
| 3D0826FR | In distribution | |
| 1D0415HL | In distribution | |
| 3D0730FN | In distribution | |
| 1D0820HL | In distribution | |
| 1D0308HL | In distribution | |
| 3D1127FR | In distribution | |
| 1D1840HL | In distribution | |
| 3D1234FR | In distribution | |
| 1D1850HL | In distribution | |
| 1D0306HL | In distribution | |
| 1D0304HL | In distribution | |
| 3D3H06FNM2 | In distribution | |
| 3D3H08FNM2 | In distribution | |
| 1D3H08HL | In distribution | |
| 1D0520HL | In distribution | |
| 3D0202FN | In distribution | |
| 1D0103HL | In distribution | |
| 3D2H08FN | In distribution | |
| 1D0515HL | In distribution | |
| 1D1H06HL | In distribution | |
| 3D2264FR | In distribution | |
| 3D0922FR | In distribution | |
| 1D0202HL | In distribution | |
| 3D4H14FNM2 | In distribution | |
| 1D0525HL | In distribution | |
| 1D1440HL | In distribution | |
| 3D0815FNM2 | In distribution | |
| 1D1655HL | In distribution | |
| 3D0102FNM2 | In distribution | |
| 3D0620FR | In distribution | |
| 3D0610FR | In distribution | |
| 3D0408FNM2 | In distribution | |
| 1D0408HL | In distribution | |
| 1D0740HL | In distribution | |
| 3D0625FNM2 | In distribution | |
| 1D0620HL | In distribution | |
| 3D0515FN | In distribution | |
| 1D1030HL | In distribution | |
| 3D0712FR | In distribution | |
| 3D0718FR | In distribution | |
| 3D3H10FN | In distribution | |
| 3D0203FN | In distribution | |
| 3D0815FR | In distribution | |
| 3D0204FNM2 | In distribution | |
| 3D0203FNM2 | In distribution | |
| 1D1H03HL | In distribution | |
| 3D0308FN | In distribution | |
| 3D1646FR | In distribution | |
| 3D0103FN | In distribution | |
| 3D1229FR | In distribution | |
| 3D0508FR | In distribution | |
| 1D0625HL | In distribution | |
| 3D2H06FN | In distribution | |
| 1D0310HL | In distribution | |
| 3D0928FR | In distribution | |
| 3D1020FR | In distribution | |
| 1D3H15HL | In distribution | |
| 3D0406FNM2 | In distribution | |
| 3D0916FR | In distribution | |
| 3D2H08FNM2 | In distribution | |
| 3D1H03FN | In distribution | |
| 1D0606HL | In distribution | |
| 3D2H03FN | In distribution | |
| 1D2H08HL | In distribution | |
| 1D0930HL | In distribution | |
| 1D0410HL | In distribution | |
| 3D0724FN | In distribution | |
| 3D0415FR | In distribution | |
| 1D1430HL | In distribution | |
| 3D1040FR | In distribution | |
| 3D0410FNM2 | In distribution | |
| 1D0206HL | In distribution | |
| 3D0310FNM2 | In distribution | |
| 1D1855HL | In distribution | |
| 1D2H03HL | In distribution | |
| 1D0730HL | In distribution | |
| 1D0940HL | In distribution | |
| 1D3H10HL | In distribution | |
| 3D1844FR | In distribution | |
| 1D3H04HL | In distribution | |
| 3D0206FN | In distribution | |
| 3D0820FN | In distribution | |
| 3D1441FR | In distribution | |
| 1D0201HL | In distribution | |
| 3D0103FNM2 | In distribution | |
| 3D0515FNM2 | In distribution | |
| 1D0615HL | In distribution | |
| 1D0508HL | In distribution | |
| 3D0815FN | In distribution | |
| 1D1255HL | In distribution | |
| 1D0608HL | In distribution | |
| 3D0730FNM2 | In distribution | |
| 3D3H10FNM2 | In distribution | |
| 3D0625FR | In distribution | |
| 3D1H04FNM2 | In distribution | |
| 3D0410FN | In distribution | |
| 3D1032FR | In distribution | |
| 3D0724FNM2 | In distribution | |
| 3D3H15FN | In distribution | |
| 1D1H01HL | In distribution | |
| 3D0202FNM2 | In distribution | |
| 1D1630HL | In distribution | |
| 3D2H04FNM2 | In distribution | |
| 3D0610FN | In distribution | |
| 3D4H08FNM2 | In distribution | |
| 3D2256FR | In distribution | |
| 3D0730FR | In distribution | |
| 1D0315HL | In distribution | |
| 3D0625FN | In distribution | |
| 3D0510FN | In distribution | |
| 3D0724FR | In distribution | |
| 1D1830HL | In distribution | |
| 1D0406HL | In distribution | |
| 3D0510FNM2 | In distribution | |
| 3D1640FR | In distribution | |
| 1D1H02HL | In distribution | |
| 3D4H18FR | In distribution | |
| 3D0208FN | In distribution | |
| 3D0206FNM2 | In distribution | |
| 1D2H04HL | In distribution | |
| 1D1040HL | In distribution | |
| 1D0420HL | In distribution | |
| 3D2461FR | In distribution | |
| 1D2H06HL | In distribution | |
| 3D0408FR | In distribution | |
| 3D0308FNM2 | In distribution | |
| 3D3H06FN | In distribution | |
| 3D4H18FN | In distribution | |
| 3D0304FNM2 | In distribution | |
| 3D0510FR | In distribution | |
| 3D2H04FN | In distribution | |
| 1D1230HL | In distribution | |
| 3D0508FNM2 | In distribution | |
| 1D1450HL | In distribution | |
| 3D1543FR | In distribution | |
| 3D0315FN | In distribution | |
| 3D1538FR | In distribution | |
| 1D0720HL | In distribution | |
| 3D0820FNM2 | In distribution | |
| 3D0826FNM2 | In distribution | |
| 3D2H06FNM2 | In distribution | |
| 3D0415FN | In distribution | |
| 3D4H18FNM2 | In distribution | |
| 1D0510HL | In distribution | |
| 3D2H03FNM2 | In distribution | |
| 3D4H10FR | In distribution | |
| 3D0208FNM2 | In distribution | |
| 3D1H03FNM2 | In distribution | |
| 1D0610HL | In distribution | |
| 1D2050HL | In distribution | |
| 1D1455HL | In distribution | |
| 3D0712FN | In distribution | |
| 3D3H15FNM2 | In distribution | |
| 3D2050FR | In distribution | |
| 1D2030HL | In distribution | |
| 3D0315FNM2 | In distribution | |
| 1D1H04HL | In distribution | |
| 3D0935FR | In distribution | |
| 1D0630HL | In distribution | |
| 3D0615FN | In distribution | |
| 3D0406FN | In distribution | |
| 1D0204HL | 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 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Barricade Coil System | Balt USA, LLC | 137 |
| Numen Helia | Microport Neurotech (Shanghai) Co., Ltd. | 129 |
| 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.