Clearance Summary
ANGIOGRAPHY SYRINGE KITS received FDA 510(k) clearance under submission number K933846, sponsored by Angiodynamics, Div. E-Z-Em, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-12-13.
- Submission: K933846
- Applicant / Sponsor: Angiodynamics, Div. E-Z-Em, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1994-12-13
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.