Clearance Summary
EKOS MICRO-INFUSION SYSTEM received FDA 510(k) clearance under submission number K053437, sponsored by Ekos Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-01-06.
- Submission: K053437
- Applicant / Sponsor: Ekos Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2006-01-06
Classification & Regulation
This clearance is catalogued under FDA product code NUI and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.