FDA 510(k)

CARDIOSAVE 體內動脈球囊泵

K 號：K181122 · 2018-05-31

決定日期2018-05-31

產品代碼DSP

諮詢委員會履歷

決定相當於

器材摘要

CARDIOSAVE Intra-Aortic Balloon Pump is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2018-05-31 under 510(k) number K181122. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARDIOSAVE Intra-Aortic Balloon Pump?

CARDIOSAVE Intra-Aortic Balloon Pump is a medical device that received FDA 510(k) clearance on 2018-05-31. The listed applicant is Datascope Corp.. The 510(k) number is K181122.

When did CARDIOSAVE Intra-Aortic Balloon Pump receive FDA 510(k) clearance?

CARDIOSAVE Intra-Aortic Balloon Pump received FDA 510(k) clearance on 2018-05-31, under 510(k) number K181122.

Who is the listed applicant for CARDIOSAVE Intra-Aortic Balloon Pump?

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

What is the FDA product code for CARDIOSAVE Intra-Aortic Balloon Pump?

The FDA product code for CARDIOSAVE Intra-Aortic Balloon Pump is DSP.

其他以 Datascope Corp. 為申請人之記錄

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相關器械（代碼：DSP）

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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官方來源

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