FDA 510(k)

Vena MicroAngioscope™ System

K-Number: K253842 · 2026-01-28

Decision Date2026-01-28

Product CodeLYK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Vena MicroAngioscope™ System is the device name listed in this FDA 510(k) record. The listed applicant is Vena Medical Holdings Corp. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K253842. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vena MicroAngioscope™ System?

Vena MicroAngioscope™ System is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Vena Medical Holdings Corp. The 510(k) number is K253842.

When did Vena MicroAngioscope™ System receive FDA 510(k) clearance?

Vena MicroAngioscope™ System received FDA 510(k) clearance on 2026-01-28, under 510(k) number K253842.

Who is the listed applicant for Vena MicroAngioscope™ System?

The FDA 510(k) record lists Vena Medical Holdings Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vena MicroAngioscope™ System?

The FDA product code for Vena MicroAngioscope™ System is LYK.

Other records listing Vena Medical Holdings Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251767Vena MicroAngioscope™ System

Related Devices (Code: LYK)

K251767Vena MicroAngioscope™ SystemVena Medical Holdings Corp

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.