510(k) K250283

RAP Femoral Venous Cannulae by LivaNova USA, Inc. — Product Code DWF

K250283 is an FDA 510(k) premarket notification submitted by LivaNova USA, Inc. for the device "RAP Femoral Venous Cannulae". The FDA issued a decision of Substantially Equivalent on July 10, 2025. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. LivaNova USA, Inc. has at least 2 other 510(k) clearances on record.