Axium™ Prime Detachable Coil System
Coil APB 3.5-10 3D-ES V06
6manufacturers in China registered for this device type
162catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Suzhou Haowei Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Micro Therapeutics, Inc., United States |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| 510(k) | K203432 |
| Record published | 2022-10-28 |
| Record revised | 2023-08-23 (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: Store in dry place, away from sunlight. |
| Distribution end date | 2026-06-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| APB-4-6-HX-SS | In distribution | |
| FC-3-6-3D | In distribution | |
| FC-6-10-3D | In distribution | |
| APB-2.5-6-3D-ES | In distribution | |
| FC-14-40-3D | In distribution | |
| APB-5-15-3D-SS | In distribution | |
| FC-25-50-3D | In distribution | |
| APB-1.5-2-HX-ES | In distribution | |
| APB-3-6-3D-ES | In distribution | |
| FC-6-20-3D | In distribution | |
| APB-3-4-HX-ES | In distribution | |
| APB-2.5-8-HX-ES | In distribution | |
| FC-8-20-3D | In distribution | |
| APB-3.5-8-3D-ES | In distribution | |
| FC-6-25-3D | In distribution | |
| APB-3-6-HX-ES | In distribution | |
| APB-4-12-HX-SS | In distribution | |
| APB-3-6-HX-ES | In distribution | |
| FC-7-12-3D | In distribution | |
| APB-2-8-HX-ES | In distribution | |
| APB-6-10-3D-SS | In distribution | |
| FC-3-10-3D | In distribution | |
| APB-6-20-3D-SS | In distribution | |
| FC-5-20-3D | In distribution | |
| APB-6-10-3D-SS | In distribution | |
| APB-2.5-6-HX-ES | In distribution | |
| APB-5-10-HX-SS | In distribution | |
| FC-7-20-3D | In distribution | |
| APB-3.5-6-3D-ES | In distribution | |
| FC-12-30-3D | In distribution | |
| FC-9-20-3D | In distribution | |
| FC-12-30-3D | In distribution | |
| FC-4-6-3D | In distribution | |
| FC-8-15-3D | In distribution | |
| FC-7-12-3D | In distribution | |
| APB-5-8-3D-SS | In distribution | |
| FC-12-40-3D | In distribution | |
| APB-3-8-3D-ES | In distribution | |
| FC-4-15-3D | In distribution | |
| FC-16-50-3D | In distribution | |
| APB-3.5-10-3D-ES | In distribution | |
| FC-5-15-3D | In distribution | |
| FC-4-12-3D | In distribution | |
| APB-1-3-3D-ES | In distribution | |
| APB-1.5-2-HX-ES | In distribution | |
| APB-4-8-3D-SS | In distribution | |
| APB-2-3-3D-ES | In distribution | |
| APB-4-6-HX-SS | In distribution | |
| APB-5-15-HX-SS | In distribution | |
| FC-10-40-3D | In distribution | |
| APB-1-4-3D-ES | In distribution | |
| APB-3-10-HX-ES | In distribution | |
| APB-2.5-4-HX-ES | In distribution | |
| APB-4-6-3D-SS | In distribution | |
| APB-2-4-3D-ES | In distribution | |
| APB-4-10-3D-SS | In distribution | |
| APB-1-2-HX-ES | In distribution | |
| FC-5-10-3D | In distribution | |
| APB-4-12-HX-SS | In distribution | |
| FC-18-50-3D | In distribution | |
| FC-16-40-3D | In distribution | |
| APB-5-8-3D-SS | In distribution | |
| FC-3.5-8-3D | In distribution | |
| APB-1-3-HX-ES | In distribution | |
| APB-2-1-HX-ES | In distribution | |
| FC-18-40-3D | In distribution | |
| FC-4-8-3D | In distribution | |
| APB-5-10-3D-SS | In distribution | |
| APB-1-2-3D-ES | In distribution | |
| APB-4-10-HX-SS | In distribution | |
| FC-3-6-3D | In distribution | |
| APB-2.5-3-HX-ES | In distribution | |
| APB-2-4-HX-ES | In distribution | |
| FC-6-20-3D | In distribution | |
| APB-4-12-3D-SS | In distribution | |
| FC-18-50-3D | In distribution | |
| APB-1.5-3-HX-ES | In distribution | |
| FC-14-50-3D | In distribution | |
| APB-2-1-HX-ES | In distribution | |
| FC-18-40-3D | In distribution | |
| APB-1.5-3-3D-ES | In distribution | |
| FC-7-15-3D | In distribution | |
| FC-8-20-3D | In distribution | |
| APB-5-8-3D-SS | In distribution | |
| APB-4-12-HX-SS | In distribution | |
| APB-6-20-3D-SS | In distribution | |
| FC-14-30-3D | In distribution | |
| FC-12-50-3D | In distribution | |
| FC-7-20-3D | In distribution | |
| APB-5-20-HX-SS | In distribution | |
| APB-6-20-3D-SS | In distribution | |
| FC-14-30-3D | In distribution | |
| APB-4-8-HX-SS | In distribution | |
| APB-2.5-6-3D-ES | In distribution | |
| APB-5-20-HX-SS | In distribution | |
| FC-3-8-3D | In distribution | |
| FC-14-50-3D | In distribution | |
| APB-4-6-HX-SS | In distribution | |
| APB-6-20-HX-SS | In distribution | |
| APB-2-2-HX-ES | In distribution | |
| FC-4-6-3D | In distribution | |
| APB-4-6-3D-SS | In distribution | |
| FC-3-8-3D | In distribution | |
| APB-4-10-HX-SS | In distribution | |
| APB-5-10-3D-SS | In distribution | |
| FC-8-20-3D | In distribution | |
| APB-6-12-HX-SS | In distribution | |
| FC-22-50-3D | In distribution | |
| FC-22-50-3D | In distribution | |
| APB-2-4-HX-ES | In distribution | |
| APB-4-8-3D-SS | In distribution | |
| FC-7-30-3D | In distribution | |
| APB-6-20-HX-SS | In distribution | |
| FC-6-25-3D | In distribution | |
| FC-10-30-3D | In distribution | |
| APB-5-15-3D-SS | In distribution | |
| APB-5-15-HX-SS | In distribution | |
| FC-5-8-3D | In distribution | |
| FC-6-15-3D | In distribution | |
| APB-3-4-3D-ES | In distribution | |
| FC-9-30-3D | In distribution | |
| APB-6-15-3D-SS | In distribution | |
| APB-6-12-HX-SS | In distribution | |
| APB-4-8-HX-SS | In distribution | |
| APB-6-12-HX-SS | In distribution | |
| FC-5-10-3D | In distribution | |
| FC-5-15-3D | In distribution | |
| FC-5-8-3D | In distribution | |
| FC-20-50-3D | In distribution | |
| APB-4-8-3D-SS | In distribution | |
| APB-2-3-HX-ES | In distribution | |
| APB-3.5-10-3D-ES | In distribution | |
| APB-5-10-3D-SS | In distribution | |
| FC-4-8-3D | In distribution | |
| FC-6-25-3D | In distribution | |
| APB-4-10-3D-SS | In distribution | |
| FC-14-50-3D | In distribution | |
| APB-5-15-HX-SS | In distribution | |
| APB-3-8-3D-ES | Withdrawn | |
| APB-2-2-HX-ES | Withdrawn | |
| APB-1-2-HX-ES | Withdrawn | |
| APB-2-8-HX-ES | Withdrawn | |
| FC-9-20-3D | Withdrawn | |
| APB-1.5-1-HX-ES | Withdrawn | |
| FC-10-40-3D | Withdrawn | |
| APB-1.5-2-3D-ES | Withdrawn | |
| APB-2.5-6-3D-ES | Withdrawn | |
| APB-1-1-HX-ES | Withdrawn | |
| APB-1-4-3D-ES | Withdrawn | |
| APB-1.5-4-HX-ES | Withdrawn | |
| APB-2.5-4-3D-ES | Withdrawn | |
| APB-1-2-3D-ES | Withdrawn | |
| APB-3-10-HX-ES | Withdrawn | |
| APB-2.5-8-HX-ES | Withdrawn | |
| APB-2.5-4-HX-ES | Withdrawn | |
| APB-1-3-HX-ES | Withdrawn | |
| APB-1-3-3D-ES | Withdrawn | |
| APB-3-4-HX-ES | Withdrawn | |
| FC-10-30-3D | Withdrawn | |
| APB-2.5-3-HX-ES | Withdrawn | |
| FC-9-30-3D | Withdrawn | |
| APB-2-4-HX-ES | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prestige Coil System | Balt USA, LLC | 339 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 279 |
| Optima Coil System | Balt USA, LLC | 255 |
| AxiumTM | Micro Therapeutics, Inc. | 255 |
| Avenir | Shanghai Wallaby Medical Technologies Co., Inc. | 184 |
| MReye | Cook Incorporated | 167 |
| Nester | Cook Incorporated | 160 |
| Axium | Micro Therapeutics, Inc. | 146 |
| ConcertoTM | Micro Therapeutics, Inc. | 133 |
| Tornado | Cook Incorporated | 111 |
| V-Trak | MicroVention, Inc. | 105 |
| HydroFrame 10 Advanced | MicroVention, Inc. | 104 |
Showing 12 of 158. All products under Device, Vascular, For Promoting Embolization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090046 | 2009-02-27 |
| K081465 | 2008-08-19 |
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 | 2022-04-27 | Class II | Labeling Change Control | Due to incorrect size and configuration labeling of the detachable coil system. | 96 systems | |
| 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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P780011 | 1988-01-29 | MINI BALLOON | Bd Becton Dickinson Vacutainer Systems Preanalytic |
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.