FDA 510(k)

Millipede 088 访问导管

K号: K214048 · 2022-09-20

决定日期2022-09-20

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

Millipede 088 Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Perfuze, Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K214048. 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 Millipede 088 Access Catheter?

Millipede 088 Access Catheter is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Perfuze, Ltd.. The 510(k) number is K214048.

When did Millipede 088 Access Catheter receive FDA 510(k) clearance?

Millipede 088 Access Catheter received FDA 510(k) clearance on 2022-09-20, under 510(k) number K214048.

Who is the listed applicant for Millipede 088 Access Catheter?

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 Millipede 088 Access Catheter?

The FDA product code for Millipede 088 Access Catheter is QJP.

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 K252392Millipede70 引流导管；Perfuze 引流管套装 K250012Millipede 070 引流导管；Perfuze 引流管套装 K240711Zipline Access 导管

查看所有 11 个设备 →

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。