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FDA 510(k)

Solex 7 血管内热交换导管，Cool Line 血管内热交换导管，ICY 血管内热交换导管，Quattro 血管内热交换导管，启动套件，Coolgard 3000 控制台，Thermogard XP 控制台

K号: K213031 · 2021-12-20

申请人Zoll Circulation, Inc.
决定日期2021-12-20
产品代码NCX
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定Unknown

器械摘要

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP 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 2021-12-20 under 510(k) number K213031. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

常见问题

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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console?

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is Zoll Circulation, Inc.. The 510(k) number is K213031.

When did Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP 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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console received FDA 510(k) clearance on 2021-12-20, under 510(k) number K213031.

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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP 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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP 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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console is NCX.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Zoll Circulation, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250979Thermogard HQ™ 温度管理系统，Thermogard XP® 温度管理系统（VitalTemp™ 通用垫）K231182Thermogard HQ™ 温度管理系统，Thermogard XP® 温度管理系统K221700AutoPulse NXT 复苏系统K223746Solex 7 血管内热交换导管，Cool Line 血管内热交换导管，ICY 血管内热交换导管，Quattro 血管内热交换导管，Thermogard XP 控制台，Thermogard HQ 控制台K220008Solex 7 血管内热交换导管，Cool Line 血管内热交换导管，ICY 血管内热交换导管，Quattro 血管内热交换导管，Thermogard HQ 启动套件，Thermogard HQ 启动套件 EX，Thermogard HQ 控制台K153226Solex 7 血管内热交换导管，ZOLL 启动套件

查看所有 7 个设备 →

相关器械（代码：NCX）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K223746Solex 7 血管内热交换导管，Cool Line 血管内热交换导管，ICY 血管内热交换导管，Quattro 血管内热交换导管，Thermogard XP 控制台，Thermogard HQ 控制台Zoll Circulation, Inc.K220008Solex 7 血管内热交换导管，Cool Line 血管内热交换导管，ICY 血管内热交换导管，Quattro 血管内热交换导管，Thermogard HQ 启动套件，Thermogard HQ 启动套件 EX，Thermogard HQ 控制台Zoll Circulation, Inc.K152946TEMPEDYSeiratherm GmbHK153162HypocoreNovocor Medical Systems, Inc.K153226Solex 7 血管内热交换导管，ZOLL 启动套件Zoll Circulation, Inc.

官方来源

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