Clearance Summary
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS received FDA 510(k) clearance under submission number K070951, sponsored by Boston Scientific. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-06-04.
- Submission: K070951
- Applicant / Sponsor: Boston Scientific
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2007-06-04
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.