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Mc3 Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1310-2024Class IINautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures October 11, 2023
Z-1309-2024Class IINautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures toOctober 11, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K232767Nautilus VF ECMO OxygenatorOctober 4, 2023
K203409MC3 Crescent Jugular Dual Lumen CatheterMay 3, 2021