510(k) K180784

ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES by Asahi Intecc Co., Ltd. — Product Code DQX

K180784 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES". The FDA issued a decision of Substantially Equivalent on Jul 18, 2018. 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.