510(k) K240190

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated by Medtronic — Product Code DTR

K240190 is an FDA 510(k) premarket notification submitted by Medtronic for the device "MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated". The FDA issued a decision of Substantially Equivalent on February 23, 2024. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Medtronic has at least 10 other 510(k) clearances on record.