Clearance Summary
CARDIAC CATHERIZATION LAB MICROPROCESS received FDA 510(k) clearance under submission number K820194, sponsored by Compu-Cath 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 1982-05-25.
- Submission: K820194
- Applicant / Sponsor: Compu-Cath Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1435
- Decision date: 1982-05-25
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.