Clearance Summary
MODEL 611101 CONTRAST INJECTION DEVICE received FDA 510(k) clearance under submission number K890898, sponsored by Medtronic Versaflex, 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 1989-04-12.
- Submission: K890898
- Applicant / Sponsor: Medtronic Versaflex, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1989-04-12
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.