FDA 510(k)

Solex 7 静脈內熱交換針，ZOLL 開發套件

K 號：K153226 · 2016-03-24

決定日期2016-03-24

產品代碼NCX

諮詢委員會履歷

決定Unknown

器材摘要

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Circulation, Inc.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K153226. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常見問題

What is the Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Zoll Circulation, Inc.. The 510(k) number is K153226.

When did Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit receive FDA 510(k) clearance?

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit received FDA 510(k) clearance on 2016-03-24, under 510(k) number K153226.

Who is the listed applicant for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

The FDA 510(k) record lists Zoll Circulation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit?

The FDA product code for Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit is NCX.

其他以 Zoll Circulation, Inc. 為申請人之記錄

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相關器械（代碼：NCX）

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