常溫保存系統用於移植最初不接受的捐贈者肺臟
PMA 核准號：P180014 · 2026-09-16
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器材摘要
Normothermic preservation system for transplantation of initially unacceptable donor lungs is the device name listed in this FDA 510(k) record. The listed applicant is Xvivo Perfusion, Inc.. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code PHO. It was reviewed by the GU advisory panel.
常見問題
What is the Normothermic preservation system for transplantation of initially unacceptable donor lungs?
Normothermic preservation system for transplantation of initially unacceptable donor lungs is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Xvivo Perfusion, Inc..
When did Normothermic preservation system for transplantation of initially unacceptable donor lungs receive FDA 510(k) clearance?
The clearance date for Normothermic preservation system for transplantation of initially unacceptable donor lungs can be found in the official FDA records.
誰是規定中列出的 Normothermic preservation system for transplantation of initially unacceptable donor lungs 的申請人？
The FDA 510(k) record lists Xvivo Perfusion, Inc. as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼是什麼？對於最初不適合移植的捐贈者肺臟的常溫保存系統？
FDA產品代碼為移植最初不接受的捐贈肺部的體溫保存系統為PHO。
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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