FDA 510(k)

貝爾澤爾UW®冷貯存解決方案（BTLBUW-001）

K 號：K243384 · 2025-03-31

決定日期2025-03-31

產品代碼KDN

諮詢委員會GU

決定相當於

器材摘要

Belzer UW® Cold Storage Solution (BTLBUW-001) is the device name listed in this FDA 510(k) record. The listed applicant is Bridge TO Life. It received FDA 510(k) clearance on 2025-03-31 under 510(k) number K243384. 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 Belzer UW® Cold Storage Solution (BTLBUW-001)?

Belzer UW® Cold Storage Solution (BTLBUW-001) is a medical device that received FDA 510(k) clearance on 2025-03-31. The listed applicant is Bridge TO Life. The 510(k) number is K243384.

When did Belzer UW® Cold Storage Solution (BTLBUW-001) receive FDA 510(k) clearance?

Belzer UW® Cold Storage Solution (BTLBUW-001) received FDA 510(k) clearance on 2025-03-31, under 510(k) number K243384.

Who is the listed applicant for Belzer UW® Cold Storage Solution (BTLBUW-001)?

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

What is the FDA product code for Belzer UW® Cold Storage Solution (BTLBUW-001)?

The FDA product code for Belzer UW® Cold Storage Solution (BTLBUW-001) is KDN.

其他以 Bridge TO Life 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。

K243618EasiSlush® 食鹽溶液，用於無菌冰沙製備 (BTLE-1250)K243840貝爾澤 MPS® (UW機器灌流解決方案) (BMPS-001)

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。

K261644Perfadex PlusXvivo Perfusion AB K260456VI°Port™ 肝臟保存系統Traferox Technologies, Inc.K254305BAROguard 腎臟捐贈保存系統Paragonix Technologies, Inc.K243618EasiSlush® 食鹽溶液，用於無菌冰沙製備 (BTLE-1250)Bridge TO Life K243870X°Port 肺部保存系統；X°Port 肺部保存解決方案Traferox Technologies, Inc.K243998DCX一次性卡式碟 (DCX)Institut Geroges Lopez

官方來源

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