510(k) K162184

Edwards eSheath Introducer Set by Edward Lifesciences — Product Code DYB

K162184 is an FDA 510(k) premarket notification submitted by Edward Lifesciences for the device "Edwards eSheath Introducer Set". The FDA issued a decision of Substantially Equivalent on September 2, 2016. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.