FDA 510(k)

Swan-Ganz Catheters

K号: K193466 · 2020-02-16

决定日期2020-02-16

产品代码DYG

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

Swan-Ganz Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2020-02-16 under 510(k) number K193466. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Swan-Ganz Catheters?

Swan-Ganz Catheters is a medical device that received FDA 510(k) clearance on 2020-02-16. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K193466.

When did Swan-Ganz Catheters receive FDA 510(k) clearance?

Swan-Ganz Catheters received FDA 510(k) clearance on 2020-02-16, under 510(k) number K193466.

Who is the listed applicant for Swan-Ganz Catheters?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Swan-Ganz Catheters?

The FDA product code for Swan-Ganz Catheters is DYG.

列明Edwards Lifesciences, LLC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。

K251326呼吸频率算法 K253186HemoSphere Nano监测仪（HSNANO1）K251982Edwards MC3 三尖瓣成形环（4900）K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)K242518高血压预测指数（HePI）算法 K242909FloTrac 传感器；FloTrac Jr 传感器；Acumen IQ 传感器；VolumeView 传感器

查看所有 53 个设备 →

相关器械（代码：DYG）

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。

K242451HemoSphere Alta高级监测平台（ALTAALL1/ALTCR1/ALTASR1）；HemoSphere Alta监测压力电缆（HEMAPSC200）；Acumen AFM电缆- HemoSphere Alta监测仪（HEMAFM100）Edwards Lifesciences K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards Lifesciences K233824Swan-Ganz catheterEdwards Lifesciences, LLC K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC K160084Swan Ganz CathetersEdwards Lifesciences, LLC

官方来源

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