Clearance Summary
UltraScore Focused Force PTA Balloon received FDA 510(k) clearance under submission number K163420, sponsored by Bard Peripheral Vascular, 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 2017-06-14.
- Submission: K163420
- Applicant / Sponsor: Bard Peripheral Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2017-06-14
Classification & Regulation
This clearance is catalogued under FDA product code PNO and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.