Clearance Summary
Cardio-TriTest v6.5 received FDA 510(k) clearance under submission number K182790, sponsored by Cardio-Phoenix, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-12-14.
- Submission: K182790
- Applicant / Sponsor: Cardio-Phoenix, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2018-12-14
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.