510(k) K252011

CHIKAI Nexus petit by Asahi Intecc Co., Ltd. — Product Code MOF

K252011 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "CHIKAI Nexus petit". The FDA issued a decision of Substantially Equivalent on February 2, 2026. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Asahi Intecc Co., Ltd. has at least 10 other 510(k) clearances on record.