Clearance Summary
MICRO-GUIDE received FDA 510(k) clearance under submission number K870700, 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 1987-12-03.
- Submission: K870700
- Applicant / Sponsor: Catheter Research C/O Burditt, Bowles & Radzius
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 1987-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.