Clearance Summary
CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT received FDA 510(k) clearance under submission number K970638, sponsored by Cardiothoracic Systems, 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 1997-10-30.
- Submission: K970638
- Applicant / Sponsor: Cardiothoracic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 1997-10-30
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.