FDA 510(k)

VitalFlow 設備組合搭配 Balance Biosurface

K 號：K240880 · 2024-09-12

決定日期2024-09-12

產品代碼QJZ

諮詢委員會履歷

決定相當於

器材摘要

VitalFlow Set with Balance Biosurface is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K240880. The device is classified under product code QJZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VitalFlow Set with Balance Biosurface?

VitalFlow Set with Balance Biosurface is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Medtronic, Inc.. The 510(k) number is K240880.

When did VitalFlow Set with Balance Biosurface receive FDA 510(k) clearance?

VitalFlow Set with Balance Biosurface received FDA 510(k) clearance on 2024-09-12, under 510(k) number K240880.

Who is the listed applicant for VitalFlow Set with Balance Biosurface?

FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for VitalFlow Set with Balance Biosurface?

The FDA product code for VitalFlow Set with Balance Biosurface is QJZ.

其他以 Medtronic, Inc. 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。

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相關器械（代碼：QJZ）

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。

K261335VitalFlow Set with Balance™ 生物表面Medtronic, Inc.K232926Novalung最終套件（美國）Fresenius Medical Care Renal Therapies Group, LLC K191407Novalung 系統Fresenius Medical Care Renal Therapies Group, LLC

官方來源

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