Clearance Summary
Ebony PTA .014 RX Pheripheral Dilatation Catheter received FDA 510(k) clearance under submission number K152230, sponsored by Natec Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-09-03.
- Submission: K152230
- Applicant / Sponsor: Natec Medical
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2015-09-03
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.