510(k) K241330

Fogarty Fortis Arterial Embolectomy Catheter by Edwards Lifesciences — Product Code DXE

K241330 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "Fogarty Fortis Arterial Embolectomy Catheter". The FDA issued a decision of Substantially Equivalent on July 2, 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.