FDA 510(k)

生命星系系統

K 號：K211830 · 2022-11-15

決定日期2022-11-15

產品代碼QNR

諮詢委員會履歷

決定相當於

器材摘要

LifeSPARC System is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K211830. 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 LifeSPARC System?

LifeSPARC System is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K211830.

When did LifeSPARC System receive FDA 510(k) clearance?

LifeSPARC System received FDA 510(k) clearance on 2022-11-15, under 510(k) number K211830.

Who is the listed applicant for LifeSPARC System?

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

What is the FDA product code for LifeSPARC System?

The FDA product code for LifeSPARC System is QNR.

其他以 Cardiacassist, Inc. 為申請人之記錄

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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。

K250199VitalFlow 控制台Medtronic, Inc.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)

官方來源

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