FDA 510(k)

ProtekDuo Mini 靜脈-靜脈針管組

K 號：K181150 · 2018-05-25

決定日期2018-05-25

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

ProtekDuo Mini Veno-Venous Cannula Set is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K181150. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProtekDuo Mini Veno-Venous Cannula Set?

ProtekDuo Mini Veno-Venous Cannula Set is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K181150.

When did ProtekDuo Mini Veno-Venous Cannula Set receive FDA 510(k) clearance?

ProtekDuo Mini Veno-Venous Cannula Set received FDA 510(k) clearance on 2018-05-25, under 510(k) number K181150.

Who is the listed applicant for ProtekDuo Mini Veno-Venous Cannula Set?

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 ProtekDuo Mini Veno-Venous Cannula Set?

The FDA product code for ProtekDuo Mini Veno-Venous Cannula Set is DWF.

其他以 Cardiacassist, 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：DWF）

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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