510(k) K163426

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension by Asahi Intecc Co., Ltd. — Product Code DQX

K163426 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension". The FDA issued a decision of Substantially Equivalent on Apr 3, 2017. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Asahi Intecc Co., Ltd. has 83 other 510(k) clearances on record.