Clearance Summary
CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER received FDA 510(k) clearance under submission number K953768, sponsored by Cordis Webster, 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 1995-11-22.
- Submission: K953768
- Applicant / Sponsor: Cordis Webster, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 1995-11-22
Classification & Regulation
This clearance is catalogued under FDA product code DRF and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.