Clearance Summary
CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL received FDA 510(k) clearance under submission number K914523, 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 1992-01-10.
- Submission: K914523
- Applicant / Sponsor: Catheter Research C/O Burditt, Bowles & Radzius
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3250
- Decision date: 1992-01-10
Classification & Regulation
This clearance is catalogued under FDA product code DSS and 21 CFR 870.3250, within the Cardiovascular review panel as a Class II device.