FDA 510(k)

器官保護HTK溶液

K 號：K241239 · 2025-01-24

決定日期2025-01-24

產品代碼KDL

諮詢委員會GU

決定相當於

器材摘要

OrganProtex HTK Solution is the device name listed in this FDA 510(k) record. The listed applicant is Bridge TO Life, Ltd.. It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K241239. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OrganProtex HTK Solution?

OrganProtex HTK Solution is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Bridge TO Life, Ltd.. The 510(k) number is K241239.

When did OrganProtex HTK Solution receive FDA 510(k) clearance?

OrganProtex HTK Solution received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241239.

Who is the listed applicant for OrganProtex HTK Solution?

The FDA 510(k) record lists Bridge TO Life, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrganProtex HTK Solution?

The FDA product code for OrganProtex HTK Solution is KDL.

其他以 Bridge TO Life, Ltd. 為申請人之記錄

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。

K203262器官灌流針管 K191006EasiSlush

相關器械（代碼：KDL）

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。

K221386PERF-GEN 閃脈灌注解決方案Institut Georges Lopez K221387BEL-GEN 冷藏解決方案Institut Georges Lopez K211842Servator M 輔助解決方案S.A.L.F. Spa K192408Custodiol HTK 溶液Dr. Franz Kohler Chemie GmbH K170150Servator H SALF 溶液-1000 ml PVC 免袋，Servator H SALF 溶液-2000 ml PVC 免袋S.A.L.F. Spa

官方來源

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