510(k) K252317

Zenith Micro Guidewire by Suzhou Zenith Vascular SciTech Limited — Product Code MOF

K252317 is an FDA 510(k) premarket notification submitted by Suzhou Zenith Vascular SciTech Limited for the device "Zenith Micro Guidewire". The FDA issued a decision of Substantially Equivalent on April 16, 2026. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Suzhou Zenith Vascular SciTech Limited has at least 3 other 510(k) clearances on record.