Clearance Summary
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD received FDA 510(k) clearance under submission number K851897, sponsored by Cardiac Control 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 1985-08-09.
- Submission: K851897
- Applicant / Sponsor: Cardiac Control Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3620
- Decision date: 1985-08-09
Classification & Regulation
This clearance is catalogued under FDA product code DTD and 21 CFR 870.3620, within the Cardiovascular review panel as a Class II device.