FDA 510(k)

Enroute 0.014'' 转颈动脉导丝

K号: K253746 · 2026-03-19

决定日期2026-03-19

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

Enroute 0.014'' Transcarotid Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K253746. 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 Enroute 0.014'' Transcarotid Guidewire?

Enroute 0.014'' Transcarotid Guidewire is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Lake Region Medical. The 510(k) number is K253746.

When did Enroute 0.014'' Transcarotid Guidewire receive FDA 510(k) clearance?

Enroute 0.014'' Transcarotid Guidewire received FDA 510(k) clearance on 2026-03-19, under 510(k) number K253746.

Who is the listed applicant for Enroute 0.014'' Transcarotid Guidewire?

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

What is the FDA product code for Enroute 0.014'' Transcarotid Guidewire?

The FDA product code for Enroute 0.014'' Transcarotid Guidewire is DQX.

列明Lake Region Medical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。

K242824PTFE 导丝 K221575预成型蓝色 K211741预成型额外支撑导丝 K160643ENROUTE 0.014 导丝

官方来源

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