太平洋加號PTA心导管
K 號：K202800 · 2020-11-18
廣告
決定日期2020-11-18
產品代碼LIT
諮詢委員會履歷
決定相當於
器材摘要
Pacific Plus PTA Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC). It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K202800. 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 Pacific Plus PTA Catheter?
Pacific Plus PTA Catheter is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC). The 510(k) number is K202800.
When did Pacific Plus PTA Catheter receive FDA 510(k) clearance?
Pacific Plus PTA Catheter received FDA 510(k) clearance on 2020-11-18, under 510(k) number K202800.
Who is the listed applicant for Pacific Plus PTA Catheter?
The FDA 510(k) record lists Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pacific Plus PTA Catheter?
The FDA product code for Pacific Plus PTA Catheter is LIT.
相關臨床試驗
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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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