Cleared Traditional

Vena MicroAngioscope? System

K251767 · Vena Medical Holdings Corp · Cardiovascular
Oct 2025
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K251767 is an FDA 510(k) clearance for the Vena MicroAngioscope? System, a Angioscope (Class II — Special Controls, product code LYK), submitted by Vena Medical Holdings Corp (Kitchener, CA). The FDA issued a Cleared decision on October 1, 2025, 113 days after receiving the submission on June 10, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K251767 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2025
Decision Date October 01, 2025
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LYK — Angioscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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