FDA 510(k)

VitalFlow 控制台

K 號：K250199 · 2025-05-20

決定日期2025-05-20

產品代碼QNR

諮詢委員會履歷

決定相當於

器材摘要

VitalFlow Console is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250199. The device is classified under product code QNR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VitalFlow Console?

VitalFlow Console is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Medtronic, Inc.. The 510(k) number is K250199.

When did VitalFlow Console receive FDA 510(k) clearance?

VitalFlow Console received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250199.

Who is the listed applicant for VitalFlow Console?

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 Console?

The FDA product code for VitalFlow Console is QNR.

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：QNR）

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。

K234118CentriMag™ 急性循環支持系統ABBOTT MEDICAL K233736生命星系系統Cardiacassist, Inc.K223898VitalFlow™ 機械式離心泵Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K230364VitalFlow™ 主控台Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)K222038CentriMag™ 血液泵，適用於與CentriMag™ 急性循環支持系統使用Abbott (Formerly Thoratec Corporation)K211830生命星系系統Cardiacassist, Inc.

官方來源

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