Micrusphere Cerecyte
MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 2.5mm x 3.3cm 190cm Contents: 1 Detachable Coil System
5manufacturers in China registered for this device type
28catalogue 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) | K082739 |
| 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; Storage environment temperature 0 to 45 °C; Storage environment temperature 32 to 110 °F; Handling environment temperature 0 to 45 °C; Handling environment temperature 32 to 110 °F |
| Distribution end date | 2021-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSP100800-30 | Withdrawn | |
| CSP100700-30 | Withdrawn | |
| CSP100600-30 | Withdrawn | |
| CSP100250-30 | Withdrawn | |
| CSP180500-30 | Withdrawn | |
| CSP181300-30 | Withdrawn | |
| CSP100350-30 | Withdrawn | |
| CSP181000-30 | Withdrawn | |
| CSP181100-30 | Withdrawn | |
| CSP180200-30 | Withdrawn | |
| CSP180800-30 | Withdrawn | |
| CSP181700-30 | Withdrawn | |
| CSP181500-30 | Withdrawn | |
| CSP180600-30 | Withdrawn | |
| CSP181600-30 | Withdrawn | |
| CSP180400-30 | Withdrawn | |
| CSP100300-30 | Withdrawn | |
| CSP101000-30 | Withdrawn | |
| CSP180300-30 | Withdrawn | |
| CSP181200-30 | Withdrawn | |
| CSP100500-30 | Withdrawn | |
| CSP100900-30 | Withdrawn | |
| CSP180900-30 | Withdrawn | |
| CSP100400-30 | Withdrawn | |
| CSP180700-30 | Withdrawn | |
| CSP100200-30 | Withdrawn | |
| CSP181400-30 | Withdrawn | |
| CSP181800-30 | 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.