FDA 510(k)

VI°Port™ 肝臟保存系統

K 號：K260456 · 2026-06-01

決定日期2026-06-01

產品代碼KDN

諮詢委員會GU

決定相當於

器材摘要

VI°Port™ Liver Preservation System is the device name listed in this FDA 510(k) record. The listed applicant is Traferox Technologies, Inc.. It received FDA 510(k) clearance on 2026-06-01 under 510(k) number K260456. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VI°Port™ Liver Preservation System?

VI°Port™ Liver Preservation System is a medical device that received FDA 510(k) clearance on 2026-06-01. The listed applicant is Traferox Technologies, Inc.. The 510(k) number is K260456.

When did VI°Port™ Liver Preservation System receive FDA 510(k) clearance?

VI°Port™ Liver Preservation System received FDA 510(k) clearance on 2026-06-01, under 510(k) number K260456.

Who is the listed applicant for VI°Port™ Liver Preservation System?

FDA 510(k) 記錄將 Traferox Technologies, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for VI°Port™ Liver Preservation System?

The FDA product code for VI°Port™ Liver Preservation System is KDN.

其他以 Traferox Technologies, Inc. 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。

K261913X°Port 心臟保護系統 K243870X°Port 肺部保存系統；X°Port 肺部保存解決方案 K240650肺保護

相關器械（代碼：KDN）

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。

K261644Perfadex PlusXvivo Perfusion AB K254305BAROguard 腎臟捐贈保存系統Paragonix Technologies, Inc.K243618EasiSlush® 食鹽溶液，用於無菌冰沙製備 (BTLE-1250)Bridge TO Life K243870X°Port 肺部保存系統；X°Port 肺部保存解決方案Traferox Technologies, Inc.K243998DCX一次性卡式碟 (DCX)Institut Geroges Lopez K243384貝爾澤爾UW®冷貯存解決方案（BTLBUW-001）Bridge TO Life

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。