FDA 510(k)

Traxcess 7 Mini XSoft 線導管

K 號：K163154 · 2016-12-09

決定日期2016-12-09

產品代碼MOF

諮詢委員會履歷

決定相當於

器材摘要

Traxcess 7 Mini XSoft 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 2016-12-09 under 510(k) number K163154. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Traxcess 7 Mini XSoft Guidewire?

Traxcess 7 Mini XSoft Guidewire is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is MicroVention, Inc.. The 510(k) number is K163154.

When did Traxcess 7 Mini XSoft Guidewire receive FDA 510(k) clearance?

Traxcess 7 Mini XSoft Guidewire received FDA 510(k) clearance on 2016-12-09, under 510(k) number K163154.

Who is the listed applicant for Traxcess 7 Mini XSoft 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 7 Mini XSoft Guidewire?

The FDA product code for Traxcess 7 Mini XSoft Guidewire is MOF.

其他以 MicroVention, Inc. 為申請人之記錄

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相關器械（代碼：MOF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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