Clearance Summary
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter received FDA 510(k) clearance under submission number K191073, sponsored by Vein 360, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-10-22.
- Submission: K191073
- Applicant / Sponsor: Vein 360, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2019-10-22
Classification & Regulation
This clearance is catalogued under FDA product code NUJ and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.