FDA 510(k)

Achieve ST Mapping导管，导管连接电缆

K号: K153139 · 2016-05-06

决定日期2016-05-06

产品代码DRF

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

Achieve ST Mapping Catheter, Catheter Connecting Cable is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K153139. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Achieve ST Mapping Catheter, Catheter Connecting Cable?

Achieve ST Mapping Catheter, Catheter Connecting Cable is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Medtronic, Inc.. The 510(k) number is K153139.

When did Achieve ST Mapping Catheter, Catheter Connecting Cable receive FDA 510(k) clearance?

Achieve ST Mapping Catheter, Catheter Connecting Cable received FDA 510(k) clearance on 2016-05-06, under 510(k) number K153139.

Who is the listed applicant for Achieve ST Mapping Catheter, Catheter Connecting Cable?

FDA 510(k)记录中列出Medtronic, Inc.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 Achieve ST Mapping Catheter, Catheter Connecting Cable?

The FDA product code for Achieve ST Mapping Catheter, Catheter Connecting Cable is DRF.

列明Medtronic, 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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官方来源

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