Clearance Summary
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) received FDA 510(k) clearance under submission number K200648, sponsored by Ekos Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-08-17.
- Submission: K200648
- Applicant / Sponsor: Ekos Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2020-08-17
Classification & Regulation
This clearance is catalogued under FDA product code QEY and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.