Optilume Basic 泌尿學氣球擴張導尿管
K 號：K191061 · 2020-01-02
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器材摘要
Optilume Basic Urological Balloon Dilation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Urotronic, Inc.. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K191061. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Optilume Basic Urological Balloon Dilation Catheter?
Optilume Basic Urological Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Urotronic, Inc.. The 510(k) number is K191061.
When did Optilume Basic Urological Balloon Dilation Catheter receive FDA 510(k) clearance?
Optilume Basic Urological Balloon Dilation Catheter received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191061.
Who is the listed applicant for Optilume Basic Urological Balloon Dilation Catheter?
The FDA 510(k) record lists Urotronic, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Optilume Basic Urological Balloon Dilation Catheter?
The FDA product code for Optilume Basic Urological Balloon Dilation Catheter is KOE.
相關臨床試驗
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其他以 Urotronic, Inc. 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。
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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