導管，氣球，尿道，藥物涂層
PMA 核准號：P210020 · 2025-06-23
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器材摘要
Catheter, Balloon, Urethral, Drug-Coated is the device name listed in this FDA 510(k) record. The listed applicant is Urotronic, Inc.. It received FDA 510(k) clearance on 2025-06-23. The device is classified under product code QRH. It was reviewed by the GU advisory panel.
常見問題
What is the Catheter, Balloon, Urethral, Drug-Coated?
Catheter, Balloon, Urethral, Drug-Coated is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Urotronic, Inc..
When did Catheter, Balloon, Urethral, Drug-Coated receive FDA 510(k) clearance?
The clearance date for Catheter, Balloon, Urethral, Drug-Coated can be found in the official FDA records.
Who is the listed applicant for Catheter, Balloon, Urethral, Drug-Coated?
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 Catheter, Balloon, Urethral, Drug-Coated?
The FDA product code for Catheter, Balloon, Urethral, Drug-Coated is QRH.
相關臨床試驗
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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