Clearance Summary
Amethyst HP PTA OTW 0.035 Catheter received FDA 510(k) clearance under submission number K251915, 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 2025-12-18.
- Submission: K251915
- Applicant / Sponsor: Natec Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2025-12-18
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.