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FDA 510(k)

Traxcess .007 Mini Guidewire

K号: K161803 · 2016-09-30

决定日期2016-09-30
产品代码MOF
咨询委员会CV
决定Substantially Equivalent

器械摘要

Traxcess .007 Mini Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161803. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Traxcess .007 Mini Guidewire?

Traxcess .007 Mini Guidewire is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is MicroVention, Inc.. The 510(k) number is K161803.

When did Traxcess .007 Mini Guidewire receive FDA 510(k) clearance?

Traxcess .007 Mini Guidewire received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161803.

Who is the listed applicant for Traxcess .007 Mini Guidewire?

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

What is the FDA product code for Traxcess .007 Mini Guidewire?

The FDA product code for Traxcess .007 Mini Guidewire is MOF.

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列明MicroVention, Inc.为申报人的其他记录

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相关器械(代码:MOF)

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。

官方来源

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