DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 1.5mm x 2cm 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.
Record
Regulatory record for Deltaplush | 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 | 2023-11-30 (version 5) |
Specifications
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; Handling 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 |
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.
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.