510(k) K163531

Advanced Perfusion System 1 by Terumo Cardiovascular Systems Corporation — Product Code DTQ

K163531 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "Advanced Perfusion System 1". The FDA issued a decision of Substantially Equivalent on June 7, 2017. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.