510(k) K230418

Mighty Wire Guide Wire by Merit Medical Systems, Inc. — Product Code DQX

K230418 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Mighty Wire Guide Wire". The FDA issued a decision of Substantially Equivalent on October 28, 2023. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.