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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)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
DCwire™FG62001023Shanghai Achieva Medical Suzhou Co., Ltd.DQX MOF06971428595864
DCwire™FG62001022Shanghai Achieva Medical Suzhou Co., Ltd.DQX MOF06971428595857
DCwire™FG62001422Shanghai Achieva Medical Suzhou Co., Ltd.DQX MOF06971428595888
DCwire™FG62001432Shanghai Achieva Medical Suzhou Co., Ltd.DQX MOF06971428595895
DCwire™FG62001433Shanghai Achieva Medical Suzhou Co., Ltd.DQX MOF06971428595925
DCwire™FG62001412Shanghai Achieva Medical Suzhou Co., Ltd.DQX MOF06971428595871
DCwire™FG62001413Shanghai Achieva Medical Suzhou Co., Ltd.DQX MOF06971428595901
DCwire™FG62001423Shanghai Achieva Medical Suzhou Co., Ltd.DQX MOF06971428595918