510(k) K240193

R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) by Sorin Group Italia S.R.L. — Product Code DWF

K240193 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)". The FDA issued a decision of Substantially Equivalent on February 22, 2024. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.