510(k) K240460

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) by FMD Co., Ltd. — Product Code DQX

K240460 is an FDA 510(k) premarket notification submitted by FMD Co., Ltd. for the device "FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)". The FDA issued a decision of Substantially Equivalent on June 13, 2024. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. FMD Co., Ltd. has at least 2 other 510(k) clearances on record.