FDA 510(k)

BAROguard 腎臟捐贈保存系統

K 號：K254305 · 2026-01-30

決定日期2026-01-30

產品代碼KDN

諮詢委員會GU

決定相當於

器材摘要

BAROguard Donor Lung Preservation System is the device name listed in this FDA 510(k) record. The listed applicant is Paragonix Technologies, Inc.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K254305. 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 BAROguard Donor Lung Preservation System?

BAROguard Donor Lung Preservation System is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Paragonix Technologies, Inc.. The 510(k) number is K254305.

When did BAROguard Donor Lung Preservation System receive FDA 510(k) clearance?

BAROguard Donor Lung Preservation System received FDA 510(k) clearance on 2026-01-30, under 510(k) number K254305.

Who is the listed applicant for BAROguard Donor Lung Preservation System?

The FDA 510(k) record lists Paragonix Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAROguard Donor Lung Preservation System?

The FDA product code for BAROguard Donor Lung Preservation System is KDN.

其他以 Paragonix Technologies, Inc. 為申請人之記錄

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K180194雪巴包心臟輸送系統及雪巴包腎臟輸送系統

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。

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