Clearance Summary
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM received FDA 510(k) clearance under submission number K983314, sponsored by Nycomed Amersham Imaging. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-02-19.
- Submission: K983314
- Applicant / Sponsor: Nycomed Amersham Imaging
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1999-02-19
Classification & Regulation
This clearance is catalogued under FDA product code IZQ and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.