FDA 510(k)

FUBUKI XF-R 神经血管长鞘

K号: K251560 · 2025-06-20

决定日期2025-06-20

产品代码QJP

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

FUBUKI XF-R Neurovascular Long Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K251560. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FUBUKI XF-R Neurovascular Long Sheath?

FUBUKI XF-R Neurovascular Long Sheath is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K251560.

When did FUBUKI XF-R Neurovascular Long Sheath receive FDA 510(k) clearance?

FUBUKI XF-R Neurovascular Long Sheath received FDA 510(k) clearance on 2025-06-20, under 510(k) number K251560.

Who is the listed applicant for FUBUKI XF-R Neurovascular Long Sheath?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUBUKI XF-R Neurovascular Long Sheath?

The FDA product code for FUBUKI XF-R Neurovascular Long Sheath is QJP.

列明Asahi Intecc Co., Ltd.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。

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