Clearance Summary
ANGIOMAT 3000, 6000, CT INJECTOR received FDA 510(k) clearance under submission number K944875, sponsored by Lievel-Flarsheim Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-01-04.
- Submission: K944875
- Applicant / Sponsor: Lievel-Flarsheim Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1995-01-04
Classification & Regulation
This clearance is catalogued under FDA product code DXT and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.