Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K252122
DCwire Micro-guidewire · Shanghai Achieva Medical Suzhou Co., Ltd. · decided 2026-03-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| DCwire™ | FG62001023 | Shanghai Achieva Medical Suzhou Co., Ltd. | DQX MOF | 06971428595864 |
| DCwire™ | FG62001022 | Shanghai Achieva Medical Suzhou Co., Ltd. | DQX MOF | 06971428595857 |
| DCwire™ | FG62001422 | Shanghai Achieva Medical Suzhou Co., Ltd. | DQX MOF | 06971428595888 |
| DCwire™ | FG62001432 | Shanghai Achieva Medical Suzhou Co., Ltd. | DQX MOF | 06971428595895 |
| DCwire™ | FG62001433 | Shanghai Achieva Medical Suzhou Co., Ltd. | DQX MOF | 06971428595925 |
| DCwire™ | FG62001412 | Shanghai Achieva Medical Suzhou Co., Ltd. | DQX MOF | 06971428595871 |
| DCwire™ | FG62001413 | Shanghai Achieva Medical Suzhou Co., Ltd. | DQX MOF | 06971428595901 |
| DCwire™ | FG62001423 | Shanghai Achieva Medical Suzhou Co., Ltd. | DQX MOF | 06971428595918 |