510(k) K212268

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT by FMD Co., Ltd. — Product Code DQX

K212268 is an FDA 510(k) premarket notification submitted by FMD Co., Ltd. for the device "FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT". The FDA issued a decision of Substantially Equivalent on May 27, 2022. 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.