Oxygenator, Long Term Support Greater Than 6 Hours

FDA product code BYS · Class II (moderate risk) · 21 CFR 870.4100 · Cardiovascular

3510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K232767Nautilus VF ECMO OxygenatorBYS · Special Mc3, Inc.10/04/2023SE
K191935Nautilus Smart ECMO ModuleBYS · Traditional Mc3 Incorporated04/09/2020SE
K770720Tubing Pack, Extracorporeal, H-3000BYS · Traditional William Harvey Life Products Corp.08/04/1977SE

Recalls

RecallProductFirmInitiated
Z-1310-2024 Class IINautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support…May have increased water path restriction within the heat exchanger, leading to degraded heat exchange… Mc3 Inc10/11/2023Open, Classified
Z-1309-2024 Class IINautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support…May have increased water path restriction within the heat exchanger, leading to degraded heat exchange… Mc3 Inc10/11/2023Open, Classified