510(k) K191464

Asahi PTCA Guide Wire Asahi SION Series by Asahi Intecc Co., Ltd. — Product Code DQX

K191464 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "Asahi PTCA Guide Wire Asahi SION Series". The FDA issued a decision of Substantially Equivalent on Nov 21, 2019. 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.