Clearance Summary
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 received FDA 510(k) clearance under submission number K971775, 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 1997-12-29.
- Submission: K971775
- Applicant / Sponsor: Cardiac Control Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 1997-12-29
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.