510(k) K212152

Prelude IDeal 9F Hydrophilic Sheath Introducer by Merit Medical Systems — Product Code DYB

K212152 is an FDA 510(k) premarket notification submitted by Merit Medical Systems for the device "Prelude IDeal 9F Hydrophilic Sheath Introducer". The FDA issued a decision of Substantially Equivalent on Jan 7, 2022. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Merit Medical Systems has 180 other 510(k) clearances on record.