Clearance Summary
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ received FDA 510(k) clearance under submission number K952638, sponsored by Baxter Edwards. 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 1995-07-28.
- Submission: K952638
- Applicant / Sponsor: Baxter Edwards
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1995-07-28
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.