FDA 510(k)

Vena 微血管内窥镜™ 系统

K号: K251767 · 2025-10-01

决定日期2025-10-01

产品代码LYK

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决定实质等同

器械摘要

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 2025-10-01 under 510(k) number K251767. The device is classified under product code LYK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vena MicroAngioscope™ System?

Vena MicroAngioscope™ System is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is Vena Medical Holdings Corp. The 510(k) number is K251767.

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

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

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.

列明Vena Medical Holdings Corp为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253842Vena 微血管内窥镜™ 系统

官方来源

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