Clearance Summary
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 received FDA 510(k) clearance under submission number K050808, sponsored by Cardio-Optics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2005-07-28.
- Submission: K050808
- Applicant / Sponsor: Cardio-Optics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2005-07-28
Classification & Regulation
This clearance is catalogued under FDA product code LYK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.