Clearance Summary
Nautilus Smart ECMO Module received FDA 510(k) clearance under submission number K191935, sponsored by Mc3 Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-04-09.
- Submission: K191935
- Applicant / Sponsor: Mc3 Incorporated
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4100
- Decision date: 2020-04-09
Classification & Regulation
This clearance is catalogued under FDA product code BYS and 21 CFR 870.4100, within the Cardiovascular review panel as a Class II device.