510(k) K232767

Nautilus VF ECMO Oxygenator by Mc3, Inc. — Product Code BYS

K232767 is an FDA 510(k) premarket notification submitted by Mc3, Inc. for the device "Nautilus VF ECMO Oxygenator". The FDA issued a decision of Substantially Equivalent on October 4, 2023. The device falls under product code BYS (Oxygenator, Long Term Support Greater Than 6 Hours), a Class II device regulated under 21 CFR 870.4100. Mc3, Inc. has at least 1 other 510(k) clearance on record.