510(k) K153143

Capiox Advance Hardshell Reservoir by Terumo Cardiovascular Systems Corporation — Product Code DTN

K153143 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "Capiox Advance Hardshell Reservoir". The FDA issued a decision of Substantially Equivalent on December 2, 2015. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.