Micrusphere
MICRUSPHERE XL microcoil MICRUSPHERE XL 18 Stretch Resistant Coil 11mm x 28cm 190cm Contents: 1 Detachable Coil System
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | KRD |
| Device type | Device, Vascular, For Promoting Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3300 |
| 510(k) | K142429 |
| Record published | 2015-09-20 |
| Record revised | 2023-11-29 (version 5) |
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; Handling environment temperature 0 to 45 °C; Handling environment temperature 32 to 110 °F; Storage environment temperature 32 to 110 °F; Storage environment temperature 0 to 45 °C |
| Distribution end date | 2021-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SSR181128-20 | Withdrawn | |
| SPH100900-20 | Withdrawn | |
| SSR181230-20 | Withdrawn | |
| SPH180200-20 | Withdrawn | |
| SSR100620-20 | Withdrawn | |
| SPH181500-20 | Withdrawn | |
| SPH100800-20 | Withdrawn | |
| SPH100500-20 | Withdrawn | |
| SPH100600-20 | Withdrawn | |
| SPH180700-20 | Withdrawn | |
| SPH180600-20 | Withdrawn | |
| SPH100720-20 | Withdrawn | |
| SPH181300-20 | Withdrawn | |
| SPH180300-20 | Withdrawn | |
| SPH181200-20 | Withdrawn | |
| SPH100200-20 | Withdrawn | |
| SSR181540-20 | Withdrawn | |
| SSR100825-20 | Withdrawn | |
| SSR181640-20 | Withdrawn | |
| SPH101030-20 | Withdrawn | |
| SSR181028-20 | Withdrawn | |
| SPH100620-20 | Withdrawn | |
| SPH100925-20 | Withdrawn | |
| SSR100510-20 | Withdrawn | |
| SSR180927-20 | Withdrawn | |
| SSR180825-20 | Withdrawn | |
| SSR100720-20 | Withdrawn | |
| SSR100408-20 | Withdrawn | |
| SSR100514-20 | Withdrawn | |
| SSR100357-20 | Withdrawn | |
| SSR181740-20 | 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 |
| 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.