Finesse™ 注射式PTA擴張球囊導管
K 號：K230263 · 2023-05-26
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器材摘要
Finesse™ Injectable PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Summa Therapeutics, LLC. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230263. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Finesse™ Injectable PTA Balloon Dilatation Catheter?
Finesse™ Injectable PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Summa Therapeutics, LLC. The 510(k) number is K230263.
When did Finesse™ Injectable PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?
Finesse™ Injectable PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230263.
Who is the listed applicant for Finesse™ Injectable PTA Balloon Dilatation Catheter?
The FDA 510(k) record lists Summa Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Finesse™ Injectable PTA Balloon Dilatation Catheter?
The FDA product code for Finesse™ Injectable PTA Balloon Dilatation Catheter is LIT.
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。
相關器械（代碼：LIT）
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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