Clearance Summary
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM received FDA 510(k) clearance under submission number K984500, sponsored by Cordis Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-12-23.
- Submission: K984500
- Applicant / Sponsor: Cordis Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1998-12-23
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.