FDA 510(k)

PROTEK Duo 31 Fr. 靜脈-靜脈針管組

K 號：K160257 · 2016-03-04

決定日期2016-03-04

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

PROTEK Duo 31 Fr. 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 2016-03-04 under 510(k) number K160257. 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 PROTEK Duo 31 Fr. Veno-Venous Cannula Set?

PROTEK Duo 31 Fr. Veno-Venous Cannula Set is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K160257.

When did PROTEK Duo 31 Fr. Veno-Venous Cannula Set receive FDA 510(k) clearance?

PROTEK Duo 31 Fr. Veno-Venous Cannula Set received FDA 510(k) clearance on 2016-03-04, under 510(k) number K160257.

Who is the listed applicant for PROTEK Duo 31 Fr. 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 PROTEK Duo 31 Fr. Veno-Venous Cannula Set?

The FDA product code for PROTEK Duo 31 Fr. Veno-Venous Cannula Set is DWF.

其他以 Cardiacassist, Inc. 為申請人之記錄

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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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