510(k) K252122

DCwire Micro-guidewire by Shanghai Achieva Medical Suzhou Co., Ltd. — Product Code MOF

K252122 is an FDA 510(k) premarket notification submitted by Shanghai Achieva Medical Suzhou Co., Ltd. for the device "DCwire Micro-guidewire". The FDA issued a decision of Substantially Equivalent on March 16, 2026. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330.