Vena MicroAngioscope System— 510(k) K253842

Name: FDA 510(k) clearance K253842
Creator: U.S. Food and Drug Administration
Published: 2026-01-28

Substantially Equivalent

Vena Medical Holdings Corp

FDA 510(k) clearance K253842 for Vena MicroAngioscope System, Substantially Equivalent on 2026-01-28. Applicant: Vena Medical Holdings Corp. Device class: 2.

Clearance details

Applicant: Vena Medical Holdings Corp
Product code: Code LYK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-02
Decision date: 2026-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kitchener, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.