FDA 510(k)

Millipede70 引流导管；Perfuze 引流管套装

K号: K252392 · 2025-08-29

决定日期2025-08-29

产品代码NRY

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

Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Perfuze, Ltd.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K252392. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set?

Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Perfuze, Ltd.. The 510(k) number is K252392.

When did Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set receive FDA 510(k) clearance?

Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set received FDA 510(k) clearance on 2025-08-29, under 510(k) number K252392.

Who is the listed applicant for Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set?

FDA 510(k)记录中列出Perfuze, Ltd.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set?

The FDA product code for Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set is NRY.

列明Perfuze, 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。

K262399Millipede 系统 K253901Millipede88接入导管 K253590Millipede 系统 K250012Millipede 070 引流导管；Perfuze 引流管套装 K240711Zipline Access 导管 K242504Millipede 088 访问导管；Millipede 070 引流导管；Perfuze 引流管套装

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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。