Deltaplush Cerecyte
DELTAPLUSH microcoil DELTAPLUSH 10 CERECYTE Coil 1.5mm x 3cm 190cm Contents: 1 Detachable Coil System
5manufacturers in China registered for this device type
16catalogue 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) | K083646 |
| 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; Storage environment temperature 32 to 110 °F; Storage environment temperature 0 to 45 °C; 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 |
|---|---|---|
| CPL100306-30 | Withdrawn | |
| CPL100153-30 | Withdrawn | |
| CPL100151-30 | Withdrawn | |
| CPL100254-30 | Withdrawn | |
| CPL100252-30 | Withdrawn | |
| CPL100201-30 | Withdrawn | |
| CPL100204-30 | Withdrawn | |
| CPL100206-30 | Withdrawn | |
| CPL100152-30 | Withdrawn | |
| CPL100408-30 | Withdrawn | |
| CPL100406-30 | Withdrawn | |
| CPL100404-30 | Withdrawn | |
| CPL100203-30 | Withdrawn | |
| CPL100304-30 | Withdrawn | |
| CPL100256-30 | Withdrawn | |
| CPL100202-30 | Withdrawn |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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 | 510(k) number | 2010-10-21 | Not classified | Other | The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm. | 6755 | 2011-01-11 |
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.