Axium
PC-10-20-HELIX Axium Helix 10MM X 20CM
6manufacturers in China registered for this device type
146catalogue 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) | K081465 |
| Record published | 2015-10-16 |
| Record revised | 2026-06-12 (version 6) |
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 1.5 to 25 mm; length 1 to 50 cm |
| Distribution end date | 2026-06-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| QC-7-30-3D | Length 30 cm | In distribution |
| PC-8-20-HELIX | Outer Diameter 8 mm | In distribution |
| PC-6-15-3D | Length 15 cm | In distribution |
| PC-4-12-3D | Primary Coil OD,.32,Millimeter;First loop diameter,2.8,Millimeter; | In distribution |
| QC-18-40-HELIX | Outer Diameter 18 mm | In distribution |
| QC-1.5-3-HELIX | Length 3 cm | In distribution |
| QC-12-30-3D | Outer Diameter 12 mm | In distribution |
| PC-3-8-HELIX | Primary Coil OD,.29,Millimeter; | In distribution |
| QC-8-20-HELIX | Length 20 cm | In distribution |
| PC-2-4-HELIX | Outer Diameter 2 mm | In distribution |
| PC-6-20-HELIX | Outer Diameter 6 mm | In distribution |
| PC-7-20-HELIX | Length 20 cm | In distribution |
| QC-9-30-3D | Length 30 cm | In distribution |
| QC-7-30-HELIX | Outer Diameter 7 mm | In distribution |
| PC-7-30-HELIX | Length 30 cm | In distribution |
| QC-16-40-3D | Outer Diameter 16 mm | In distribution |
| QC-7-15-3D | Outer Diameter 7 mm | In distribution |
| QC-18-40-3D | Length 40 cm | In distribution |
| PC-8-15-3D | Primary Coil OD,.34,Millimeter;First loop diameter,5.6,Millimeter; | In distribution |
| QC-6-15-3D | Length 15 cm | In distribution |
| QC-2.5-4-HELIX | Outer Diameter 2.5 mm | In distribution |
| QC-2-1-HELIX | Outer Diameter 2 mm | In distribution |
| QC-16-40-HELIX | Outer Diameter 16 mm | In distribution |
| QC-2-4-HELIX | Length 4 cm | In distribution |
| QC-7-20-HELIX | Length 20 cm | In distribution |
| QC-3.5-15-3D | Outer Diameter 3.5 mm | In distribution |
| QC-2.5-4-3D | Outer Diameter 2.5 mm | In distribution |
| QC-12-40-3D | Length 40 cm | In distribution |
| QC-3.5-12-3D | Length 12 cm | In distribution |
| PC-5-8-3D | Length 8 cm | In distribution |
| PC-3-6-HELIX | Primary Coil OD,.29,Millimeter; | In distribution |
| QC-3-8-3D | Outer Diameter 3 mm | In distribution |
| QC-2.5-6-3D | Length 6 cm | In distribution |
| NC-4-8-HELIX | Outer Diameter 4 mm | In distribution |
| QC-2.5-8-HELIX | Outer Diameter 2.5 mm | In distribution |
| QC-8-15-3D | Length 15 cm | In distribution |
| QC-8-30-HELIX | Outer Diameter 8 mm | In distribution |
| PC-3-4-3D | Length 4 cm | In distribution |
| PC-4-6-3D | Outer Diameter 4 mm | In distribution |
| PC-9-30-HELIX | Length 30 cm | In distribution |
| PC-7-15-3D | Outer Diameter 7 mm | In distribution |
| QC-5-8-3D | Outer Diameter 5 mm | In distribution |
| QC-2-8-HELIX | Outer Diameter 2 mm | In distribution |
| PC-6-10-3D | Outer Diameter 6 mm | In distribution |
| QC-20-50-3D | Length 50 cm | In distribution |
| NC-2-6-HELIX | Outer Diameter 2 mm | In distribution |
| QC-12-30-HELIX | Length 30 cm | In distribution |
| NC-2-2-HELIX | Length 2 cm | In distribution |
| PC-9-20-HELIX | Outer Diameter 9 mm | In distribution |
| QC-10-30-3D | Outer Diameter 10 mm | In distribution |
| PC-14-40-3D | Outer Diameter 14 mm | In distribution |
| QC-4-12-3D | Length 12 cm | In distribution |
| QC-5-10-3D | Outer Diameter 5 mm | In distribution |
| QC-14-30-3D | Outer Diameter 14 mm | In distribution |
| PC-6-20-3D | Length 20 cm | In distribution |
| PC-3-8-3D | Primary Coil OD,.29,Millimeter;First loop diameter,2.1,Millimeter; | In distribution |
| QC-2-2-3D | Length 2 cm | In distribution |
| PC-18-40-3D | Primary Coil OD,.37,Millimeter;First loop diameter,12.6,Millimeter; | In distribution |
| PC-8-20-3D | Outer Diameter 8 mm | In distribution |
| PC-4-10-HELIX | Length 10 cm | In distribution |
| QC-3-6-HELIX | Length 6 cm | In distribution |
| PC-12-30-3D | Length 30 cm | In distribution |
| QC-10-30-HELIX | Length 30 cm | In distribution |
| PC-4-8-HELIX | Length 8 cm | In distribution |
| PC-2-3-HELIX | Length 3 cm | In distribution |
| QC-3-10-3D | Length 10 cm | In distribution |
| QC-1.5-4-HELIX | Outer Diameter 1.5 mm | In distribution |
| NC-3-6-HELIX | Length 6 cm | In distribution |
| QC-5-15-3D | Length 15 cm | In distribution |
| QC-22-50-3D | Length 50 cm | In distribution |
| PC-2-4-3D | Outer Diameter 2 mm | In distribution |
| QC-2-6-3D | Outer Diameter 2 mm | In distribution |
| QC-8-30-3D | Outer Diameter 8 mm | In distribution |
| QC-2-6-HELIX | Length 6 cm | In distribution |
| PC-5-20-HELIX | Outer Diameter 5 mm | In distribution |
| NC-3-4-HELIX | Outer Diameter 3 mm | In distribution |
| QC-10-20-3D | Length 20 cm | In distribution |
| QC-3-8-HELIX | Length 8 cm | In distribution |
| PC-5-15-3D | Length 15 cm | In distribution |
| PC-7-20-3D | Length 20 cm | In distribution |
| PC-4-8-3D | Outer Diameter 4 mm | In distribution |
| PC-9-20-3D | Outer Diameter 9 mm | In distribution |
| NC-3-8-HELIX | Length 8 cm | In distribution |
| QC-2.5-2-3D | Outer Diameter 2.5 mm | In distribution |
| PC-2-8-HELIX | Length 8 cm | In distribution |
| PC-2-2-HELIX | Primary Coil OD,.29,Millimeter; | In distribution |
| PC-2-6-HELIX | Length 6 cm | In distribution |
| PC-14-30-3D | Outer Diameter 14 mm | In distribution |
| PC-4-10-3D | Primary Coil OD,.32,Millimeter;First loop diameter,2.8,Millimeter; | In distribution |
| PC-5-10-3D | Primary Coil OD,.32,Millimeter;First loop diameter,3.5,Millimeter; | In distribution |
| QC-25-50-3D | Length 50 cm | In distribution |
| QC-14-30-HELIX | Outer Diameter 14 mm | In distribution |
| PC-10-30-HELIX | Length 30 cm | In distribution |
| PC-16-40-3D | Outer Diameter 16 mm | In distribution |
| QC-9-30-HELIX | Length 30 cm | In distribution |
| PC-7-30-3D | Length 30 cm | In distribution |
| QC-3-4-3D | Outer Diameter 3 mm | In distribution |
| PC-9-30-3D | Length 30 cm | In distribution |
| PC-2-6-3D | Length 6 cm | In distribution |
| QC-3-4-HELIX | Length 4 cm | In distribution |
| PC-10-20-3D | Length 20 cm | In distribution |
| QC-2.5-6-HELIX | Outer Diameter 2.5 mm | In distribution |
| PC-10-20-HELIX | Length 20 cm | In distribution |
| PC-4-12-HELIX | Primary Coil OD,.32,Millimeter; | In distribution |
| NC-2-3-HELIX | Outer Diameter 2 mm | In distribution |
| PC-3-4-HELIX | Primary Coil OD,.29,Millimeter; | In distribution |
| QC-2-3-HELIX | Length 3 cm | In distribution |
| QC-9-20-3D | Outer Diameter 9 mm | In distribution |
| QC-14-40-3D | Outer Diameter 14 mm | In distribution |
| QC-8-20-3D | Outer Diameter 8 mm | In distribution |
| QC-1.5-2-HELIX | Outer Diameter 1.5 mm | In distribution |
| QC-2.5-8-3D | Length 8 cm | In distribution |
| PC-2-1-HELIX | Primary Coil OD,.29,Millimeter; | In distribution |
| QC-4-6-3D | Length 6 cm | In distribution |
| QC-6-20-3D | Length 20 cm | In distribution |
| PC-8-30-HELIX | Length 30 cm | In distribution |
| QC-7-20-3D | Outer Diameter 7 mm | In distribution |
| QC-2-4-3D | Length 4 cm | In distribution |
| NC-2-1-HELIX | Primary Coil OD,.29,Millimeter; | In distribution |
| QC-3.5-6-3D | Outer Diameter 3.5 mm | In distribution |
| QC-10-20-HELIX | Length 20 cm | In distribution |
| QC-3-6-3D | Length 6 cm | In distribution |
| PC-12-40-3D | Length 40 cm | In distribution |
| QC-4-8-3D | Outer Diameter 4 mm | In distribution |
| PC-5-15-HELIX | Outer Diameter 5 mm | In distribution |
| QC-9-20-HELIX | Length 20 cm | In distribution |
| PC-2-2-3D | Primary Coil OD,.29,Millimeter;First loop diameter,1.5,Millimeter; | In distribution |
| PC-10-30-3D | Outer Diameter 10 mm | In distribution |
| QC-2-2-HELIX | Outer Diameter 2 mm | In distribution |
| NC-2-4-HELIX | Length 4 cm | In distribution |
| PC-3-6-3D | Length 6 cm | In distribution |
| PC-8-30-3D | Length 30 cm | In distribution |
| QC-2.5-2-HELIX | Length 2 cm | In distribution |
| QC-20-50-HELIX | Outer Diameter 20 mm | In distribution |
| QC-6-20-HELIX | Outer Diameter 6 mm | Withdrawn |
| QC-5-20-HELIX | Length 20 cm | Withdrawn |
| QC-4-12-HELIX | Outer Diameter 4 mm | Withdrawn |
| QC-5-15-HELIX | Length 15 cm | Withdrawn |
| QC-20-40-HELIX | Length 40 cm | Withdrawn |
| QC-12-40-HELIX | Length 40 cm | Withdrawn |
| QC-4-10-HELIX | Outer Diameter 4 mm | Withdrawn |
| QC-4-8-HELIX | Outer Diameter 4 mm | Withdrawn |
| QC-16-30-HELIX | Outer Diameter 16 mm | Withdrawn |
| QC-4-10-3D | Length 10 cm | Withdrawn |
| QC-6-10-3D | Outer Diameter 6 mm | Withdrawn |
| QC-14-40-HELIX | Length 40 cm | 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 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 162 |
| Nester | Cook Incorporated | 160 |
| 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 | 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 |
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.