FDA 510(k)

LINQ II®植入式心脏监测器（ICM）

K号: K240693 · 2024-03-28

决定日期2024-03-28

产品代码MXD

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

LINQ II™ Insertable Cardiac Monitor (ICM) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2024-03-28 under 510(k) number K240693. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LINQ II™ Insertable Cardiac Monitor (ICM)?

LINQ II™ Insertable Cardiac Monitor (ICM) is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Medtronic, Inc.. The 510(k) number is K240693.

When did LINQ II™ Insertable Cardiac Monitor (ICM) receive FDA 510(k) clearance?

LINQ II™ Insertable Cardiac Monitor (ICM) received FDA 510(k) clearance on 2024-03-28, under 510(k) number K240693.

Who is the listed applicant for LINQ II™ Insertable Cardiac Monitor (ICM)?

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 LINQ II™ Insertable Cardiac Monitor (ICM)?

The FDA product code for LINQ II™ Insertable Cardiac Monitor (ICM) is MXD.

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。

K262913Protégé™ EverFlex™ 自膨胀外周支架系统 K262735LINQ II 可植入式心脏监测器（ICM）（LNQ22）K262005Affera 集成映射系统 K261335VitalFlow Set with Balance™ 生物表面套装 K261866Concerto Versa® 可拆卸线圈 K260195延长型单件动脉（EOPA）3D® 动脉导管

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官方来源

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