Avenir Mega Coil System
35 catalogue numbers from 18HMG05020, listed by Shanghai Wallaby Medical Technologies Co., Inc., China, 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 | Shanghai Wallaby Medical Technologies Co., Inc., China |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2024-10-11 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18HMG05020 | In distribution | |
| 18HMG05015 | In distribution | |
| 18HMG04015 | In distribution | |
| 18HMG05010 | In distribution | |
| 18HMG03006 | In distribution | |
| 18HMG04020 | In distribution | |
| 18HMG10040 | In distribution | |
| 18HMG09035 | In distribution | |
| 18CMG10040 | In distribution | |
| 18HMG12040 | In distribution | |
| 18HMG06010 | In distribution | |
| 18CMG04020 | In distribution | |
| 18CMG04015 | In distribution | |
| 18HMG06030 | In distribution | |
| 18CMG06030 | In distribution | |
| 18HMG08030 | In distribution | |
| 18CMG08030 | In distribution | |
| 18CMG07030 | In distribution | |
| 18CMG05020 | In distribution | |
| 18HMG03010 | In distribution | |
| 18CMG03015 | In distribution | |
| 18HMG03015 | In distribution | |
| 18CMG04010 | In distribution | |
| 18CMG05015 | In distribution | |
| 18HMG07030 | In distribution | |
| 18HMG04010 | In distribution | |
| 18HMG06020 | In distribution | |
| 18CMG03006 | In distribution | |
| 18HMG11040 | In distribution | |
| 18CMG03010 | In distribution | |
| 18CMG09035 | In distribution | |
| 18CMG05010 | In distribution | |
| 18CMG07020 | In distribution | |
| 18CMG06020 | In distribution | |
| 18HMG07020 | 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
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.