Axium Prime
19 catalogue numbers from APB-5-8-3D-SS, listed by Micro Therapeutics, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for 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) | K081465 |
| Record published | 2015-10-16 |
| Record revised | 2021-02-05 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Sizes | Outer diameter 4 to 6 mm; length 6 to 20 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| APB-5-8-3D-SS | Outer Diameter 5 mm | In distribution |
| APB-4-8-3D-SS | Outer Diameter 4 mm | In distribution |
| APB-5-15-HX-SS | Outer Diameter 5 mm | In distribution |
| APB-4-10-3D-SS | Length 10 cm | In distribution |
| APB-5-10-HX-SS | Outer Diameter 5 mm | In distribution |
| APB-6-20-HX-SS | Outer Diameter 6 mm | In distribution |
| APB-4-6-HX-SS | Outer Diameter 4 mm | In distribution |
| APB-6-12-HX-SS | Outer Diameter 6 mm | In distribution |
| APB-6-20-3D-SS | Outer Diameter 6 mm | In distribution |
| APB-5-10-3D-SS | Length 10 cm | In distribution |
| APB-6-15-3D-SS | Outer Diameter 6 mm | In distribution |
| APB-5-20-HX-SS | Outer Diameter 5 mm | In distribution |
| APB-4-8-HX-SS | Length 8 cm | In distribution |
| APB-4-6-3D-SS | Length 6 cm | In distribution |
| APB-4-12-HX-SS | Length 12 cm | In distribution |
| APB-4-12-3D-SS | Outer Diameter 4 mm | In distribution |
| APB-6-10-3D-SS | Length 10 cm | In distribution |
| APB-4-10-HX-SS | Outer Diameter 4 mm | In distribution |
| APB-5-15-3D-SS | Outer Diameter 5 mm | In distribution |
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 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 162 |
| Nester | Cook Incorporated | 160 |
| Axium | Micro Therapeutics, Inc. | 146 |
| ConcertoTM | Micro Therapeutics, Inc. | 133 |
| Tornado | Cook Incorporated | 111 |
| V-Trak | MicroVention, Inc. | 105 |
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
1 recall names this product by its own identifier, 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. | 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.