Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

About This 510(k) Submission

K240666 is an FDA 510(k) clearance for the Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS), a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on July 10, 2024, 124 days after receiving the submission on March 8, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.