FDA 510(k)

Heli-FX施用器，Heli-FX引导器，辅助内镜锚定卡式盒

K号: K171427 · 2017-06-13

决定日期2017-06-13

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 Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette 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 2017-06-13 under 510(k) number K171427. 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 Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette?

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette is a medical device that received FDA 510(k) clearance on 2017-06-13. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K171427.

When did Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette receive FDA 510(k) clearance?

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette received FDA 510(k) clearance on 2017-06-13, under 510(k) number K171427.

Who is the listed applicant for Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette?

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 Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette?

The FDA product code for Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette 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。

K182957Heli-FX内镜锚定系统 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 K161361HawkOne定向旋切系统

官方来源

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