FDA 510(k)

CS100/CS100i 體內動脈球囊泵，CS300 體內動脈球囊泵

K 號：K172305 · 2017-10-12

決定日期2017-10-12

產品代碼DSP

諮詢委員會履歷

決定相當於

器材摘要

CS100/CS100i Intra-Aortic Balloon Pump, CS300 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 2017-10-12 under 510(k) number K172305. 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 CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump?

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Datascope Corp.. The 510(k) number is K172305.

When did CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump receive FDA 510(k) clearance?

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump received FDA 510(k) clearance on 2017-10-12, under 510(k) number K172305.

Who is the listed applicant for CS100/CS100i Intra-Aortic Balloon Pump, CS300 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 CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump?

The FDA product code for CS100/CS100i Intra-Aortic Balloon Pump, CS300 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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