510(k) K262086

PreludeSYNC™ Radial Compression Device by Merit Medical Systems, Inc. — Product Code DXC

K262086 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "PreludeSYNC™ Radial Compression Device". The FDA issued a decision of Substantially Equivalent on July 22, 2026. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.