FDA 510(k)

0.014" Willow导丝

K号: K253168 · 2025-11-26

决定日期2025-11-26

产品代码MOF

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

0.014” Willow Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Arbor Endovascular, LLC. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K253168. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 0.014” Willow Guidewire?

0.014” Willow Guidewire is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Arbor Endovascular, LLC. The 510(k) number is K253168.

When did 0.014” Willow Guidewire receive FDA 510(k) clearance?

0.014” Willow Guidewire received FDA 510(k) clearance on 2025-11-26, under 510(k) number K253168.

Who is the listed applicant for 0.014” Willow Guidewire?

FDA 510(k)记录中列出了Arbor Endovascular, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for 0.014” Willow Guidewire?

The FDA product code for 0.014” Willow Guidewire is MOF.

列明Arbor Endovascular, 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。

K262424Willow 12 导丝 K260537Willow 24 导丝 K260130Willow 18 导丝 K2437560.014" Willow导丝

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。