510(k) K202125

Century Perfusion System by Century Hlm, LLC — Product Code DTQ

K202125 is an FDA 510(k) premarket notification submitted by Century Hlm, LLC for the device "Century Perfusion System". The FDA issued a decision of Substantially Equivalent on March 7, 2021. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220.