FDA 510(k)

Branchor X 气球引导导管

K号: K251240 · 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

Branchor X Balloon Guide Catheter 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 K251240. 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 Branchor X Balloon Guide Catheter?

Branchor X Balloon Guide Catheter 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 K251240.

When did Branchor X Balloon Guide Catheter receive FDA 510(k) clearance?

Branchor X Balloon Guide Catheter received FDA 510(k) clearance on 2025-06-20, under 510(k) number K251240.

Who is the listed applicant for Branchor X Balloon Guide Catheter?

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 Branchor X Balloon Guide Catheter?

The FDA product code for Branchor X Balloon Guide Catheter 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。

K254178SAYA 86 桡动脉通路导丝导管 K252011CHIKAI Nexus petit K251560FUBUKI XF-R 神经血管长鞘 K243383CHIKAI Nexus 014 K243733SION blue PLUS K241962Crossloop

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官方来源

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