FDA 510(k)

Go2Wire 引導絲

K 號：K193571 · 2020-04-08

決定日期2020-04-08

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

Go2Wire Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical System, Inc.. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K193571. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Go2Wire Guide Wire?

Go2Wire Guide Wire is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Merit Medical System, Inc.. The 510(k) number is K193571.

When did Go2Wire Guide Wire receive FDA 510(k) clearance?

Go2Wire Guide Wire received FDA 510(k) clearance on 2020-04-08, under 510(k) number K193571.

Who is the listed applicant for Go2Wire Guide Wire?

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

What is the FDA product code for Go2Wire Guide Wire?

The FDA product code for Go2Wire Guide Wire is DQX.

其他以 Merit Medical System, Inc. 為申請人之記錄

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官方來源

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