510(k) K173750

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

K173750 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Prelude IDeal Hydrophilic Sheath Introducer". The FDA issued a decision of Substantially Equivalent on Feb 15, 2018. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.