510(k) K240078

Fogarty Thru-Lumen Embolectomy Catheter by Edwards Lifesciences, LLC — Product Code DXE

K240078 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Fogarty Thru-Lumen Embolectomy Catheter". The FDA issued a decision of Substantially Equivalent on August 28, 2024. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.