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FDA 510(k)

Solex 7 静脈內熱交換針，Cool Line 静脈內熱交換針，ICY 静脈內熱交換針，Quattro 静脈內熱交換針，Thermogard HQ 開始套件，Thermogard HQ 開始套件 EX，Thermogard HQ 控制台

K 號：K220008 · 2022-06-02

申請人Zoll Circulation, Inc.
決定日期2022-06-02
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, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console 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 2022-06-02 under 510(k) number K220008. 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, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console?

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is Zoll Circulation, Inc.. The 510(k) number is K220008.

When did Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console receive FDA 510(k) clearance?

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console received FDA 510(k) clearance on 2022-06-02, under 510(k) number K220008.

Who is the listed applicant for Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console?

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, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console?

The FDA product code for Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console is NCX.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Zoll Circulation, 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。

K250979Thermogard HQ™ 體溫管理系統，Thermogard XP® 體溫管理系統（VitalTemp™ 大眾型墊）K231182Thermogard HQ™ 體溫管理系統，Thermogard XP® 體溫管理系統K221700AutoPulse NXT 救援系統K223746Solex 7 静脈內熱交換針，Cool Line 静脈內熱交換針，ICY 静脈內熱交換針，Quattro 静脈內熱交換針，Thermogard XP 控制台，Thermogard HQ 控制台K213031Solex 7 體內熱交換針，Cool Line 體內熱交換針，ICY 體內熱交換針，Quattro 體內熱交換針，啟動套件，Coolgard 3000 控制台，Thermogard XP 控制台K153226Solex 7 静脈內熱交換針，ZOLL 開發套件

查看所有 7 項裝置 →

相關器械（代碼：NCX）

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。

K223746Solex 7 静脈內熱交換針，Cool Line 静脈內熱交換針，ICY 静脈內熱交換針，Quattro 静脈內熱交換針，Thermogard XP 控制台，Thermogard HQ 控制台Zoll Circulation, Inc.K213031Solex 7 體內熱交換針，Cool Line 體內熱交換針，ICY 體內熱交換針，Quattro 體內熱交換針，啟動套件，Coolgard 3000 控制台，Thermogard XP 控制台Zoll Circulation, Inc.K152946TEMPEDYSeiratherm GmbHK153162低核心Novocor Medical Systems, Inc.K153226Solex 7 静脈內熱交換針，ZOLL 開發套件Zoll Circulation, Inc.

官方來源

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