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FDA 510(k)

峰值左心室通气导管，20 Fr；峰值左心室通气导管，18 Fr；峰值左心室通气导管，16 Fr

K号: K170488 · 2017-08-10

申请人Surge Cardiovascular
决定日期2017-08-10
产品代码DWF
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。
决定实质等同

器械摘要

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is the device name listed in this FDA 510(k) record. The listed applicant is Surge Cardiovascular. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K170488. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Surge Cardiovascular. The 510(k) number is K170488.

When did Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr receive FDA 510(k) clearance?

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr received FDA 510(k) clearance on 2017-08-10, under 510(k) number K170488.

Who is the listed applicant for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

The FDA 510(k) record lists Surge Cardiovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

The FDA product code for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is DWF.

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

相关器械（代码：DWF）

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。

K260195延长型单件动脉（EOPA）3D® 动脉导管Medtronic, Inc.K250937静脉回流导管LivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203逆行冠状动脉窦灌注导管Medtronic, Inc.K253671双阶段静脉导管Sorin Group Italia S.R.L.K253998Clearview 冠状动脉内分流管Medtronic, Inc.

官方来源

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