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FDA 510(k)

Radifocus Glidewire Advantage Track

K 號：K163004 · 2017-01-30

申請人Ashitaka Factory of Terumo Coporation
決定日期2017-01-30
產品代碼DQX
諮詢委員會履歷
決定相當於

器材摘要

Radifocus Glidewire Advantage Track is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Coporation. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K163004. 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 Radifocus Glidewire Advantage Track?

Radifocus Glidewire Advantage Track is a medical device that received FDA 510(k) clearance on 2017-01-30. The listed applicant is Ashitaka Factory of Terumo Coporation. The 510(k) number is K163004.

When did Radifocus Glidewire Advantage Track receive FDA 510(k) clearance?

Radifocus Glidewire Advantage Track received FDA 510(k) clearance on 2017-01-30, under 510(k) number K163004.

Who is the listed applicant for Radifocus Glidewire Advantage Track?

The FDA 510(k) record lists Ashitaka Factory of Terumo Coporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radifocus Glidewire Advantage Track?

The FDA product code for Radifocus Glidewire Advantage Track is DQX.

相關臨床試驗

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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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