510(k) K233820

Fogarty Arterial Embolectomy Catheter with Gate Valve by Edwards Lifesciences — Product Code DXE

K233820 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "Fogarty Arterial Embolectomy Catheter with Gate Valve". The FDA issued a decision of Substantially Equivalent on May 22, 2024. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Edwards Lifesciences has at least 10 other 510(k) clearances on record.