FDA 510(k)

Gunther郁金香下腔静脉滤器回收套件

K号: K222254 · 2023-05-16

决定日期2023-05-16

产品代码MMX

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

Gunther Tulip Vena Cava Filter Retrieval Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222254. The device is classified under product code MMX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gunther Tulip Vena Cava Filter Retrieval Set?

Gunther Tulip Vena Cava Filter Retrieval Set is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Cook Incorporated. The 510(k) number is K222254.

When did Gunther Tulip Vena Cava Filter Retrieval Set receive FDA 510(k) clearance?

Gunther Tulip Vena Cava Filter Retrieval Set received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222254.

Who is the listed applicant for Gunther Tulip Vena Cava Filter Retrieval Set?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gunther Tulip Vena Cava Filter Retrieval Set?

The FDA product code for Gunther Tulip Vena Cava Filter Retrieval Set is MMX.

列明Cook Incorporated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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官方来源

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