Compass BDS 胆道支架
K 號：K213946 · 2022-05-09
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器材摘要
Compass BDS Biliary Stent is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2022-05-09 under 510(k) number K213946. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Compass BDS Biliary Stent?
Compass BDS Biliary Stent is a medical device that received FDA 510(k) clearance on 2022-05-09. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K213946.
When did Compass BDS Biliary Stent receive FDA 510(k) clearance?
Compass BDS Biliary Stent received FDA 510(k) clearance on 2022-05-09, under 510(k) number K213946.
Who is the listed applicant for Compass BDS Biliary Stent?
FDA 510(k) 記錄將 Cook Ireland, Ltd. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Compass BDS Biliary Stent?
The FDA product code for Compass BDS Biliary Stent is FGE.
相關臨床試驗
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其他以 Cook Ireland, 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。
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相關器械（代碼：FGE）
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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