Micrusphere
MICRUSPHERE XL microcoil MICRUSPHERE XL 18 Stretch Resistant Coil 13mm x 34cm 190cm Contents: 1 Detachable Coil System
5manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Microport Neurotech (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | HCG |
| Device type | Device, Neurovascular Embolization |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5950 |
| 510(k) | K142429 |
| Record published | 2015-09-20 |
| Record revised | 2023-11-30 (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; Storage environment temperature 0 to 45 °C; Storage environment temperature 32 to 110 °F; Handling environment temperature 32 to 110 °F |
| Distribution end date | 2021-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPH181700-20 | Withdrawn | |
| SSR181334-20 | Withdrawn | |
| SSR181840-20 | Withdrawn | |
| SPH100700-20 | Withdrawn | |
| SPH180800-20 | Withdrawn | |
| SPH100350-20 | Withdrawn | |
| SSR100225-20 | Withdrawn | |
| SPH181000-20 | Withdrawn | |
| SPH100300-20 | Withdrawn | |
| SSR100816-20 | Withdrawn | |
| SSR100612-20 | Withdrawn | |
| SSR100714-20 | Withdrawn | |
| SPH181400-20 | Withdrawn | |
| SPH180400-20 | Withdrawn | |
| SPH101000-20 | Withdrawn | |
| SPH100825-20 | Withdrawn | |
| SSR100253-20 | Withdrawn | |
| SSR181436-20 | Withdrawn | |
| SPH181600-20 | Withdrawn | |
| SPH181800-20 | Withdrawn | |
| SPH180900-20 | Withdrawn | |
| SPH100250-20 | Withdrawn | |
| SPH100400-20 | Withdrawn | |
| SSR100305-20 | Withdrawn | |
| SSR100410-20 | Withdrawn | |
| SPH181100-20 | Withdrawn | |
| SPH180500-20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optima Coil System | Balt USA, LLC | 307 |
| Penumbra Coil 400 | Penumbra Inc. | 268 |
| Smart Coil | Penumbra Inc. | 238 |
| Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 234 |
| Numen | Microport Neurotech (Shanghai) Co., Ltd. | 223 |
| Axium™ Prime Detachable Coil System | Micro Therapeutics, Inc. | 141 |
| Barricade Coil System | Balt USA, LLC | 137 |
| Numen Helia | Microport Neurotech (Shanghai) Co., Ltd. | 129 |
| V-Trak | MicroVention, Inc. | 106 |
| HydroSoft Helical | MicroVention, Inc. | 94 |
| AxiumTM | Micro Therapeutics, Inc. | 89 |
| LP Coil System | Penumbra Inc. | 77 |
Showing 12 of 99. All products under Device, Neurovascular Embolization
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.