FDA 510(k)

肺保護

K 號：K240650 · 2024-11-26

決定日期2024-11-26

產品代碼KDN

諮詢委員會GU

決定相當於

器材摘要

LungProtect 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 2024-11-26 under 510(k) number K240650. 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 LungProtect?

LungProtect is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Traferox Technologies, Inc.. The 510(k) number is K240650.

When did LungProtect receive FDA 510(k) clearance?

LungProtect received FDA 510(k) clearance on 2024-11-26, under 510(k) number K240650.

Who is the listed applicant for LungProtect?

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 LungProtect?

The FDA product code for LungProtect 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 K260456VI°Port™ 肝臟保存系統 K243870X°Port 肺部保存系統；X°Port 肺部保存解決方案

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 K260456VI°Port™ 肝臟保存系統Traferox Technologies, Inc.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

官方來源

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