510(k) K244046

Edwards eSheath Optima introducer set by Edwards Lifesciences — Product Code DYB

K244046 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "Edwards eSheath Optima introducer set". The FDA issued a decision of Substantially Equivalent on March 27, 2025. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Edwards Lifesciences has at least 10 other 510(k) clearances on record.