Clearance Summary
CARDIOVENTION CORX SYSTEM, MODEL FG 0001 received FDA 510(k) clearance under submission number K012325, sponsored by Cardiovention, 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 2002-04-09.
- Submission: K012325
- Applicant / Sponsor: Cardiovention, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4360
- Decision date: 2002-04-09
Classification & Regulation
This clearance is catalogued under FDA product code KFM and 21 CFR 870.4360, within the Cardiovascular review panel as a Class II device.