510(k) K200358

Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula by Edwards Lifesciences, LLC — Product Code DWF

K200358 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula". The FDA issued a decision of Substantially Equivalent on Mar 13, 2020. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Edwards Lifesciences, LLC has 157 other 510(k) clearances on record.