510(k) K182110

CDI Blood Parameter Monitoring System 550 by Terumo Cardiovascular Systems Corporation — Product Code DRY

K182110 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "CDI Blood Parameter Monitoring System 550". The FDA issued a decision of Substantially Equivalent on November 2, 2018. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.