FDA 510(k)

TXM亲水导丝

K号: K170915 · 2017-11-21

决定日期2017-11-21

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

TXM Hydrophilic Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K170915. 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 TXM Hydrophilic Guidewire?

TXM Hydrophilic Guidewire is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Texasmedical Technologies, Inc.. The 510(k) number is K170915.

When did TXM Hydrophilic Guidewire receive FDA 510(k) clearance?

TXM Hydrophilic Guidewire received FDA 510(k) clearance on 2017-11-21, under 510(k) number K170915.

Who is the listed applicant for TXM Hydrophilic Guidewire?

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

What is the FDA product code for TXM Hydrophilic Guidewire?

The FDA product code for TXM Hydrophilic Guidewire is DQX.

列明Texasmedical Technologies, 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。

K170914TXM支撑导管 K153771TXM引导鞘 K153703引导导管 K153125IntraNovo 微导管

官方来源

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