FDA 510(k)

VenaTech® LP 腔静脉滤器系统和 VenaTech® 可转换腔静脉滤器系统

K号: K240578 · 2024-07-31

决定日期2024-07-31

产品代码DTK

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

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K240578. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System?

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K240578.

When did VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System receive FDA 510(k) clearance?

VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System received FDA 510(k) clearance on 2024-07-31, under 510(k) number K240578.

Who is the listed applicant for VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System?

FDA 510(k)记录中列出了B.Braun Medical, Inc.为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System?

The FDA product code for VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System is DTK.

列明B.Braun 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。

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相关器械（代码：DTK）

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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官方来源

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