FDA 510(k)

Go2Wire 导丝

K号: K193571 · 2020-04-08

决定日期2020-04-08

产品代码DQX

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

Go2Wire Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical System, Inc.. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K193571. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Go2Wire Guide Wire?

Go2Wire Guide Wire is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Merit Medical System, Inc.. The 510(k) number is K193571.

When did Go2Wire Guide Wire receive FDA 510(k) clearance?

Go2Wire Guide Wire received FDA 510(k) clearance on 2020-04-08, under 510(k) number K193571.

Who is the listed applicant for Go2Wire Guide Wire?

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

What is the FDA product code for Go2Wire Guide Wire?

The FDA product code for Go2Wire Guide Wire is DQX.

列明Merit Medical System, 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。

K252527Surfacer Inside-Out 访问导管系统 K231468SCOUT MD 外科引导系统 K230636Maestro 微导管 K212817Merit Siege血管塞

官方来源

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