FDA 510(k)

Protek Duo 靜脈擴張器組合包，Protek Solo 靜脈擴張器組合包

K 號：K162181 · 2017-01-06

決定日期2017-01-06

產品代碼DRE

諮詢委員會履歷

決定相當於

器材摘要

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator 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 2017-01-06 under 510(k) number K162181. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K162181.

When did Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set receive FDA 510(k) clearance?

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set received FDA 510(k) clearance on 2017-01-06, under 510(k) number K162181.

Who is the listed applicant for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator 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 Venous Dilator Set, Protek Solo Venous Dilator Set?

The FDA product code for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set is DRE.

其他以 Cardiacassist, Inc. 為申請人之記錄

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相關器械（代碼：DRE）

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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