510(k) K162843

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 by Terumo Cardiovascular Systems Corporation — Product Code DWB

K162843 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1". The FDA issued a decision of Substantially Equivalent on November 17, 2016. The device falls under product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type), a Class II device regulated under 21 CFR 870.4370. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.