Clearance Summary
QUANTIEN Measurement System received FDA 510(k) clearance under submission number K183099, sponsored by St. Jude Medical (Now Abbott Medical). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-02-28.
- Submission: K183099
- Applicant / Sponsor: St. Jude Medical (Now Abbott Medical)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2019-02-28
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.