Clearance Summary
VAS-CATH DSA CATHETER/TRAY received FDA 510(k) clearance under submission number K834232, 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 1984-04-24.
- Submission: K834232
- Applicant / Sponsor: Vas-Cath of Canada , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1984-04-24
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.