FDA 510(k)

Capiox iCP 超速離心泵

K 號：K200091 · 2021-11-18

申請人Terumo Cardiovascular Systems Corporation

決定日期2021-11-18

產品代碼KFM

諮詢委員會履歷

決定相當於

器材摘要

Capiox iCP Centrifugal Pump is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K200091. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Capiox iCP Centrifugal Pump?

Capiox iCP Centrifugal Pump is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K200091.

When did Capiox iCP Centrifugal Pump receive FDA 510(k) clearance?

Capiox iCP Centrifugal Pump received FDA 510(k) clearance on 2021-11-18, under 510(k) number K200091.

Who is the listed applicant for Capiox iCP Centrifugal Pump?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capiox iCP Centrifugal Pump?

The FDA product code for Capiox iCP Centrifugal Pump is KFM.

其他以 Terumo Cardiovascular Systems Corporation 為申請人之記錄

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相關器械（代碼：KFM）

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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