FDA 510(k)

Vena 微血管顯微鏡™ 系統

K 號：K251767 · 2025-10-01

決定日期2025-10-01

產品代碼LYK

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Vena Medical Holdings Corp 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253842Vena 微血管顯微鏡™ 系統

相關器械（代碼：LYK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253842Vena 微血管顯微鏡™ 系統Vena Medical Holdings Corp

官方來源

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