510(k) K241521

Prelude Small O.D. Introducer Guide Wire by Merit Medical Systems, Inc. — Product Code DQX

K241521 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Prelude Small O.D. Introducer Guide Wire". The FDA issued a decision of Substantially Equivalent on December 10, 2024. 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.