Clearance Summary
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance under submission number K112513, sponsored by Natec Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-12-09.
- Submission: K112513
- Applicant / Sponsor: Natec Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2011-12-09
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.