Clearance Summary
OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS received FDA 510(k) clearance under submission number K844800, sponsored by Vas-Cath of Canada , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-05-16.
- Submission: K844800
- Applicant / Sponsor: Vas-Cath of Canada , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 1985-05-16
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.