簡單導管
K 號：K182511 · 2019-03-20
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器材摘要
SimplCath is the device name listed in this FDA 510(k) record. The listed applicant is F&S Medical Solutions, LLC. It received FDA 510(k) clearance on 2019-03-20 under 510(k) number K182511. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SimplCath?
SimplCath is a medical device that received FDA 510(k) clearance on 2019-03-20. The listed applicant is F&S Medical Solutions, LLC. The 510(k) number is K182511.
When did SimplCath receive FDA 510(k) clearance?
SimplCath received FDA 510(k) clearance on 2019-03-20, under 510(k) number K182511.
Who is the listed applicant for SimplCath?
The FDA 510(k) record lists F&S Medical Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SimplCath?
The FDA product code for SimplCath is GBM.
相關臨床試驗
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相關器械（代碼：GBM）
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。
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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