Clearance Summary
FOCUS PC BALLOON DILATATION CATHETER received FDA 510(k) clearance under submission number K954313, sponsored by Cardio-Dynamics, 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 1995-12-01.
- Submission: K954313
- Applicant / Sponsor: Cardio-Dynamics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1995-12-01
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.