FDA 510(k)

Heli-FX内镜锚定系统

K号: K182957 · 2018-11-21

决定日期2018-11-21

产品代码OTD

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

Heli-FX EndoAnchor System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182957. The device is classified under product code OTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Heli-FX EndoAnchor System?

Heli-FX EndoAnchor System is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K182957.

When did Heli-FX EndoAnchor System receive FDA 510(k) clearance?

Heli-FX EndoAnchor System received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182957.

Who is the listed applicant for Heli-FX EndoAnchor System?

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

What is the FDA product code for Heli-FX EndoAnchor System?

The FDA product code for Heli-FX EndoAnchor System is OTD.

列明Medtronic Vascular, 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。

K171866Sentrant Introducer Sheath with Hydrophilic Coating K170191SilverHawk 外周斑块切除术系统，TurboHawk 外周斑块切除术系统 K171427Heli-FX施用器，Heli-FX引导器，辅助内镜锚定卡式盒 K161361HawkOne定向旋切系统

官方来源

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