FDA 510(k)

R2P Radifocus Glidewire 優勢

K 號：K240818 · 2024-11-26

決定日期2024-11-26

產品代碼DQX

諮詢委員會履歷

決定相當於

器材摘要

R2P Radifocus Glidewire Advantage is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K240818. 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 R2P Radifocus Glidewire Advantage?

R2P Radifocus Glidewire Advantage is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Terumo Corporation. The 510(k) number is K240818.

When did R2P Radifocus Glidewire Advantage receive FDA 510(k) clearance?

R2P Radifocus Glidewire Advantage received FDA 510(k) clearance on 2024-11-26, under 510(k) number K240818.

Who is the listed applicant for R2P Radifocus Glidewire Advantage?

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

What is the FDA product code for R2P Radifocus Glidewire Advantage?

The FDA product code for R2P Radifocus Glidewire Advantage is DQX.

其他以 Terumo Corporation 為申請人之記錄

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相關器械（代碼：DQX）

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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