標準標準供體肺臟移植前之常溫灌流系統
PMA 核准號：P160013 · 2026-05-13
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器材摘要
常見問題
What is the Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation?
Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is TransMedics, Inc..
When did Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation receive FDA 510(k) clearance?
The clearance date for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation can be found in the official FDA records.
Who is the listed applicant for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation?
The FDA 510(k) record lists TransMedics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation?
The FDA product code for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation is QBA.
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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