Clearance Summary
CONTRAST INJECTION DEVICE received FDA 510(k) clearance under submission number K880877, sponsored by Med-West, 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 1988-05-31.
- Submission: K880877
- Applicant / Sponsor: Med-West, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1988-05-31
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.