Clearance Summary
CRI CYNOSAR CATHETER received FDA 510(k) clearance under submission number K904785, sponsored by Catheter Research C/O Burditt, Bowles & Radzius. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-03-06.
- Submission: K904785
- Applicant / Sponsor: Catheter Research C/O Burditt, Bowles & Radzius
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1280
- Decision date: 1991-03-06
Classification & Regulation
This clearance is catalogued under FDA product code DRA and 21 CFR 870.1280, within the Cardiovascular review panel as a Class II device.