Clearance Summary
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating received FDA 510(k) clearance under submission number K142983, sponsored by Angioscore, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-03-04.
- Submission: K142983
- Applicant / Sponsor: Angioscore, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2015-03-04
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.