510(k) K233619

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters by Edwards Lifesciences — Product Code DXE

K233619 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters". The FDA issued a decision of Substantially Equivalent on May 20, 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.