Helipaq Cerecyte
HELIPAQ microcoil HELIPAQ 18 CERECYTE Coil 18mm x 30cm 190cm Contents: 1 Detachable Coil System
5manufacturers in China registered for this device type
52catalogue 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; Handling environment temperature 32 to 110 °F; Storage environment temperature 32 to 110 °F; Storage environment temperature 0 to 45 °C; Handling environment temperature 0 to 45 °C |
| Distribution end date | 2021-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CHE100930-30 | Withdrawn | |
| CHE181830-30 | Withdrawn | |
| CHE101030-30 | Withdrawn | |
| CHE100730-30 | Withdrawn | |
| CHE100310-30 | Withdrawn | |
| CHE180610-30 | Withdrawn | |
| CHE180930-30 | Withdrawn | |
| CHE100815-30 | Withdrawn | |
| CHE100915-30 | Withdrawn | |
| CHE100308-30 | Withdrawn | |
| CHE100610-30 | Withdrawn | |
| CHE180830-30 | Withdrawn | |
| CHE100720-30 | Withdrawn | |
| CHE180512-30 | Withdrawn | |
| CHE181430-30 | Withdrawn | |
| CHE101020-30 | Withdrawn | |
| CHE180520-30 | Withdrawn | |
| CHE180730-30 | Withdrawn | |
| CHE100515-30 | Withdrawn | |
| CHE100820-30 | Withdrawn | |
| CHE100306-30 | Withdrawn | |
| CHE180204-30 | Withdrawn | |
| CHE181030-30 | Withdrawn | |
| CHE180410-30 | Withdrawn | |
| CHE181630-30 | Withdrawn | |
| CHE100206-30 | Withdrawn | |
| CHE100204-30 | Withdrawn | |
| CHE100410-30 | Withdrawn | |
| CHE100710-30 | Withdrawn | |
| CHE100304-30 | Withdrawn | |
| CHE100520-30 | Withdrawn | |
| CHE180820-30 | Withdrawn | |
| CHE100620-30 | Withdrawn | |
| CHE100404-30 | Withdrawn | |
| CHE100203-30 | Withdrawn | |
| CHE100715-30 | Withdrawn | |
| CHE100615-30 | Withdrawn | |
| CHE100408-30 | Withdrawn | |
| CHE180620-30 | Withdrawn | |
| CHE101015-30 | Withdrawn | |
| CHE100201-30 | Withdrawn | |
| CHE100406-30 | Withdrawn | |
| CHE100208-30 | Withdrawn | |
| CHE100830-30 | Withdrawn | |
| CHE100202-30 | Withdrawn | |
| CHE180915-30 | Withdrawn | |
| CHE100810-30 | Withdrawn | |
| CHE100510-30 | Withdrawn | |
| CHE100920-30 | Withdrawn | |
| CHE181230-30 | Withdrawn | |
| CHE182030-30 | Withdrawn | |
| CHE180308-30 | 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.