Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter— 510(k) K191073

Name: FDA 510(k) clearance K191073
Creator: U.S. Food and Drug Administration
Published: 2019-10-22

Substantially Equivalent

Vein 360, LLC

FDA 510(k) clearance K191073 for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter, Substantially Equivalent on 2019-10-22. Applicant: Vein 360, LLC. Device class: 2.

Clearance details

Applicant: Vein 360, LLC
Product code: Code NUJ
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2019-04-22
Decision date: 2019-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Ash, OH, US

Download summary PDF View on FDA.gov ↗

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