FDA 510(k)

8F改进的套管系统

K号: K240529 · 2024-10-02

决定日期2024-10-02

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

8F Modified Sheath System is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K240529. 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 8F Modified Sheath System?

8F Modified Sheath System is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K240529.

When did 8F Modified Sheath System receive FDA 510(k) clearance?

8F Modified Sheath System received FDA 510(k) clearance on 2024-10-02, under 510(k) number K240529.

Who is the listed applicant for 8F Modified Sheath System?

FDA 510(k)记录将Route 92 Medical, Inc.列为申请人。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 8F Modified Sheath System?

The FDA product code for 8F Modified Sheath System is QJP.

列明Route 92 Medical, Inc.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。

K26022092医疗全长046接入系统 K243601Route 92 医疗 HiPoint 再灌注系统和吸引管套装 K233329Route 92 医疗全长 054 再灌注系统和吸引管套装 K231583Route 92 医疗全长 054 访问系统 K223530Route 92 医疗全长 070 再灌注系统和吸引管套装 K222743Route 92 医疗全长 070 访问系统

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官方来源

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