510(k) K260606

Echo Large Bore Introducer Sheath by Echo Medical, LLC — Product Code DYB

K260606 is an FDA 510(k) premarket notification submitted by Echo Medical, LLC for the device "Echo Large Bore Introducer Sheath". The FDA issued a decision of Substantially Equivalent on April 29, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.