Clearance Summary
Cardio-TriTest received FDA 510(k) clearance under submission number K143432, sponsored by Cardio-Phoenix, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-06-03.
- Submission: K143432
- Applicant / Sponsor: Cardio-Phoenix, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2015-06-03
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.