常溫灌流機器，用於移植前保存捐贈者肝臟
PMA 核准號：P200035 · 2026-08-07
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器材摘要
Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is the device name listed in this FDA 510(k) record. The listed applicant is Organox Limited. It received FDA 510(k) clearance on 2026-08-07. The device is classified under product code QQK. It was reviewed by the GU advisory panel.
常見問題
What is the Normothermic machine perfusion system for the preservation of donor livers prior to transplantation?
Normothermic machine perfusion system for the preservation of donor livers prior to transplantation is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Organox Limited.
When did Normothermic machine perfusion system for the preservation of donor livers prior to transplantation receive FDA 510(k) clearance?
The clearance date for Normothermic machine perfusion system for the preservation of donor livers prior to transplantation can be found in the official FDA records.
誰是規定中為捐贈者肝臟移植前保存之體溫機械灌流系統的申請人？
The FDA 510(k) record lists Organox Limited as the applicant. This does not by itself establish the device manufacturer.
何為FDA產品代碼，用於在移植前保存捐贈肝臟的常溫灌流系統？
FDA產品代碼為捐贈肝臟移植前保存的常溫灌流系統為QQK。
相關臨床試驗
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。
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。
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