Clearance Summary
ARTLINE received FDA 510(k) clearance under submission number K160448, sponsored by Health Line International Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-07-12.
- Submission: K160448
- Applicant / Sponsor: Health Line International Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2016-07-12
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.