510(k) K211898

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 by Asahi Intecc Co., Ltd. — Product Code DQX

K211898 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20". The FDA issued a decision of Substantially Equivalent on December 8, 2021. 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 at least 10 other 510(k) clearances on record.