導入鞘套組
K 號：K222184 · 2023-02-21
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器材摘要
Introducer Sheath Kits is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-02-21 under 510(k) number K222184. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Introducer Sheath Kits?
Introducer Sheath Kits is a medical device that received FDA 510(k) clearance on 2023-02-21. The listed applicant is Beijing Demax Medical Technology Co.,Ltd. The 510(k) number is K222184.
When did Introducer Sheath Kits receive FDA 510(k) clearance?
Introducer Sheath Kits received FDA 510(k) clearance on 2023-02-21, under 510(k) number K222184.
Who is the listed applicant for Introducer Sheath Kits?
The FDA 510(k) record lists Beijing Demax Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Introducer Sheath Kits?
The FDA product code for Introducer Sheath Kits is DYB.
相關臨床試驗
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其他以 Beijing Demax Medical Technology Co.,Ltd 為申請人之記錄
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。
相關器械（代碼：DYB）
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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