Axium PrimeTM
Coil APB-2.5-6-HX-ES V04
5manufacturers in China registered for this device type
39catalogue numbers in this listing
11510(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 | Micro Therapeutics, Inc., United States |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| 510(k) | K162704 |
| Record published | 2019-06-20 |
| Record revised | 2026-06-11 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Keep away from sunlight, Store product in a dry, cool place. |
| Distribution end date | 2026-06-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FC-4-8-3D | In distribution | |
| APB-2-2-HX-ES | In distribution | |
| APB-1.5-1-HX-ES | In distribution | |
| APB-2-8-HX-ES | In distribution | |
| APB-1-1-HX-ES | In distribution | |
| APB-1-3-HX-ES | In distribution | |
| FC-8-20-3D | In distribution | |
| APB-1-2-3D-ES | In distribution | |
| APB-3-4-3D-ES | In distribution | |
| FC-4-6-3D | In distribution | |
| FC-5-20-3D | In distribution | |
| APB-2.5-4-HX-ES | In distribution | |
| APB-1.5-2-3D-ES | In distribution | |
| FC-5-10-3D | In distribution | |
| APB-2-2-3D-ES | In distribution | |
| FC-3.5-6-3D | Withdrawn | |
| FC-10-20-3D | Withdrawn | |
| APB-4-6-3D-SS | Withdrawn | |
| FC-7-20-3D | Withdrawn | |
| FC-14-30-3D | Withdrawn | |
| FC-12-30-3D | Withdrawn | |
| FC-14-40-3D | Withdrawn | |
| FC-12-40-3D | Withdrawn | |
| APB-2-1-HX-ES | Withdrawn | |
| APB-2.5-6-HX-ES | Withdrawn | |
| FC-6-20-3D | Withdrawn | |
| APB-1.5-4-HX-ES | Withdrawn | |
| FC-20-50-3D | Withdrawn | |
| FC-4-10-3D | Withdrawn | |
| FC-7-15-3D | Withdrawn | |
| FC-3.5-10-3D | Withdrawn | |
| FC-16-50-3D | Withdrawn | |
| FC-3-10-3D | Withdrawn | |
| APB-2.5-8-HX-ES | Withdrawn | |
| FC-14-50-3D | Withdrawn | |
| FC-25-50-3D | Withdrawn | |
| APB-6-12-HX-SS | Withdrawn | |
| FC-18-40-3D | Withdrawn | |
| FC-7-12-3D | Withdrawn |
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 |
| 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 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060747 | 2007-04-24 |
| K060625 | 2006-04-20 |
| K051560 | 2005-06-28 |
| K051425 | 2005-06-22 |
| K050543 | 2005-04-27 |
| K041649 | 2004-07-16 |
| K040694 | 2004-03-25 |
| K033372 | 2004-01-09 |
| K032497 | 2003-09-25 |
| K031852 | 2003-08-20 |
| K030392 | 2003-07-21 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2010-03-01 | Not classified | Employee error | ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production. | 13 units | 2012-01-31 |
| Covidien | 510(k) number | 2010-03-01 | Not classified | Employee error | ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production. | 14 units | 2012-01-31 |
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.