510(k) K183070

ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 by Asahi Intecc Co., Ltd. — Product Code MOF

K183070 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010". The FDA issued a decision of Substantially Equivalent on Jan 29, 2019. 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 83 other 510(k) clearances on record.