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FDA 510(k)

Vena MicroAngioscope™ System

K-Number: K251767 · 2025-10-01

Decision Date2025-10-01
Product CodeLYK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vena MicroAngioscope™ System is a medical device manufactured by Vena Medical Holdings Corp. It received FDA 510(k) clearance on 2025-10-01 under approval number K251767. 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 2025-10-01. It is manufactured by Vena Medical Holdings Corp. The 510(k) number is K251767.

When was Vena MicroAngioscope™ System approved by the FDA?

Vena MicroAngioscope™ System received FDA 510(k) clearance on 2025-10-01, under approval number K251767.

What company makes Vena MicroAngioscope™ System?

Vena MicroAngioscope™ System is manufactured by Vena Medical Holdings Corp.

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

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

Other Devices by Vena Medical Holdings Corp

Related Devices (Code: LYK)

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.