SureAx-Guide™
K 號：K250203 · 2025-10-17
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器材摘要
SureAx-Guide™ is the device name listed in this FDA 510(k) record. The listed applicant is Sureax Medical, LLC. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K250203. 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 SureAx-Guide™?
SureAx-Guide™ is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Sureax Medical, LLC. The 510(k) number is K250203.
When did SureAx-Guide™ receive FDA 510(k) clearance?
SureAx-Guide™ received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250203.
Who is the listed applicant for SureAx-Guide™?
The FDA 510(k) record lists Sureax Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SureAx-Guide™?
The FDA product code for SureAx-Guide™ is DQX.
相關臨床試驗
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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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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