510(k) K193379

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe by Edwards Lifesciences, LLC — Product Code DXE

K193379 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe". The FDA issued a decision of Substantially Equivalent on June 12, 2020. 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.