Vena MicroAngioscope System— 510(k) K251767

Name: FDA 510(k) clearance K251767
Creator: U.S. Food and Drug Administration
Published: 2025-10-01

Substantially Equivalent

Vena Medical Holdings Corp

FDA 510(k) clearance K251767 for Vena MicroAngioscope System, Substantially Equivalent on 2025-10-01. 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: 2025-06-10
Decision date: 2025-10-01
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.