PSM 3向式矽膠福樸導尿管
K 號：K181616 · 2018-09-21
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器材摘要
PSM 3-Way Silicone Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pathway, LLC. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K181616. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PSM 3-Way Silicone Foley Catheter?
PSM 3-Way Silicone Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Pathway, LLC. The 510(k) number is K181616.
When did PSM 3-Way Silicone Foley Catheter receive FDA 510(k) clearance?
PSM 3-Way Silicone Foley Catheter received FDA 510(k) clearance on 2018-09-21, under 510(k) number K181616.
Who is the listed applicant for PSM 3-Way Silicone Foley Catheter?
The FDA 510(k) record lists Pathway, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PSM 3-Way Silicone Foley Catheter?
The FDA product code for PSM 3-Way Silicone Foley Catheter is EZL.
相關臨床試驗
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其他以 Pathway, LLC 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：EZL）
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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