510(k) K200612

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line by Sorin Group Italia S.R.L. — Product Code DWF

K200612 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "R501 aortic root cannula without vent line, R502 aortic root cannula with vent line". The FDA issued a decision of Substantially Equivalent on November 17, 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. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.