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FDA PMA

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:P250025 · 2026-07-15

決定日期2026-07-15
PMA 編號P250025
產品代碼PHO
器械分類3 類
醫療專科U
諮詢委員會GU

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 Traferox Technologies, Inc.. It received FDA 510(k) clearance on 2026-07-15. 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 2026-07-15. The listed applicant is Traferox Technologies, 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?

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。

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

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官方來源

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