Vena MicroAngioscope System
K-Number: K253842 · 2026-01-28
ApplicantVena Medical Holdings Corp
Decision Date2026-01-28
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 2026-01-28 under approval 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. It is manufactured by Vena Medical Holdings Corp. The 510(k) number is K253842.
When was Vena MicroAngioscope System approved by the FDA?
Vena MicroAngioscope System received FDA 510(k) clearance on 2026-01-28, under approval number K253842.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.