FDA 510(k)

Sphere-9Dx 诊断导管 (AFR-00009)

K号: K233433 · 2024-08-07

决定日期2024-08-07

产品代码MTD

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

Sphere-9Dx Diagnostic Catheter (AFR-00009) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2024-08-07 under 510(k) number K233433. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sphere-9Dx Diagnostic Catheter (AFR-00009)?

Sphere-9Dx Diagnostic Catheter (AFR-00009) is a medical device that received FDA 510(k) clearance on 2024-08-07. The listed applicant is Medtronic. The 510(k) number is K233433.

When did Sphere-9Dx Diagnostic Catheter (AFR-00009) receive FDA 510(k) clearance?

Sphere-9Dx Diagnostic Catheter (AFR-00009) received FDA 510(k) clearance on 2024-08-07, under 510(k) number K233433.

Who is the listed applicant for Sphere-9Dx Diagnostic Catheter (AFR-00009)?

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

What is the FDA product code for Sphere-9Dx Diagnostic Catheter (AFR-00009)?

The FDA product code for Sphere-9Dx Diagnostic Catheter (AFR-00009) is MTD.

列明Medtronic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：MTD）

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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