510(k) K261640

Merit MAK Nitinol/Gold-Tungsten Guide Wire by Merit Medical Ireland , Ltd. — Product Code DQX

K261640 is an FDA 510(k) premarket notification submitted by Merit Medical Ireland , Ltd. for the device "Merit MAK Nitinol/Gold-Tungsten Guide Wire". The FDA issued a decision of Substantially Equivalent on July 13, 2026. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Merit Medical Ireland , Ltd. has at least 5 other 510(k) clearances on record.