Clearance Summary
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure received FDA 510(k) clearance under submission number K192838, sponsored by Spectrum Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-04-13.
- Submission: K192838
- Applicant / Sponsor: Spectrum Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4380
- Decision date: 2020-04-13
Classification & Regulation
This clearance is catalogued under FDA product code DWA and 21 CFR 870.4380, within the Cardiovascular review panel as a Class II device.