510(k) K260105

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts by Edwards Lifesciences — Product Code DXC

K260105 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts". The FDA issued a decision of Substantially Equivalent on June 5, 2026. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Edwards Lifesciences has at least 10 other 510(k) clearances on record.