510(k) K260544

FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 by FMD Co., Ltd. — Product Code DQX

K260544 is an FDA 510(k) premarket notification submitted by FMD Co., Ltd. for the device "FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40". The FDA issued a decision of Substantially Equivalent on March 20, 2026. 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.