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Medtronic Perfusion Systems

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2024-07-10
TypeNumberDevice NameCodeDateActions
510(k) K240666 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)DTZ2024-07-10 View
510(k) K181954 autoLog IQ Autotransfusion SystemCAC2018-08-22 View