Clearance Summary
POLY-TECH ANGIOGRAPHY CATHETER received FDA 510(k) clearance under submission number K862030, sponsored by Poly-Tech Medical Device Research & Development. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-08-08.
- Submission: K862030
- Applicant / Sponsor: Poly-Tech Medical Device Research & Development
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 1986-08-08
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.