510(k) K250937

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

K250937 is an FDA 510(k) premarket notification submitted by LivaNova USA, Inc. for the device "Venous Return Cannulae". The FDA issued a decision of Substantially Equivalent on March 11, 2026. 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.