Clearance Summary
BAIM CORONARY SINUS FLOW ANALYZER received FDA 510(k) clearance under submission number K811414, sponsored by Electro-Catheter Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-06-12.
- Submission: K811414
- Applicant / Sponsor: Electro-Catheter Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1981-06-12
Classification & Regulation
This clearance is catalogued under FDA product code DXG and 21 CFR 870.1435, within the Cardiovascular review panel as a Class II device.