FDA 510(k)

Impress 血管造影导管

K号: K233268 · 2024-05-22

决定日期2024-05-22

产品代码DQO

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

Impress Angiographic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K233268. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Impress Angiographic Catheter?

Impress Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K233268.

When did Impress Angiographic Catheter receive FDA 510(k) clearance?

Impress Angiographic Catheter received FDA 510(k) clearance on 2024-05-22, under 510(k) number K233268.

Who is the listed applicant for Impress Angiographic Catheter?

FDA 510(k)记录中列出了Merit Medical Systems, Inc.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 Impress Angiographic Catheter?

The FDA product code for Impress Angiographic Catheter is DQO.

列明Merit Medical Systems, 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：DQO）

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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