MVR? Venous Reservoir Bag 800 mL; MVR? Venous Reservoir Bag 1600 mL; MVR? Venous Reservoir Bag with Cortiva? BioActive Surface 800 mL; MVR? Venous Reservoir Bag with Cortiva? BioActive Surface 1600 mL

About This 510(k) Submission

K241053 is an FDA 510(k) clearance for the MVR? Venous Reservoir Bag 800 mL; MVR? Venous Reservoir Bag 1600 mL; MVR? Venous Reservoir Bag with Cortiva? BioActive Surface 800 mL; MVR? Venous Reservoir Bag with Cortiva? BioActive Surface 1600 mL, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Medtronic Cardiac Surgery (Mounds View, US). The FDA issued a Cleared decision on May 15, 2024, 28 days after receiving the submission on April 17, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.