510(k) K170583

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface by Medtronic, Inc. — Product Code DTN

K170583 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface". The FDA issued a decision of Substantially Equivalent on March 17, 2017. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Medtronic, Inc. has at least 10 other 510(k) clearances on record.