510(k) K250909

Prelude Wave Hydrophilic Sheath Introducer by Merit Medical Systems, Inc. — Product Code DYB

K250909 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Prelude Wave Hydrophilic Sheath Introducer". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.