014 水性包裝 PTA 擴張導管
K 號：K171251 · 2017-09-08
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器材摘要
014 Hydrophilic Coated PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Creagh Medical. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K171251. 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 014 Hydrophilic Coated PTA Balloon Dilatation Catheter?
014 Hydrophilic Coated PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Creagh Medical. The 510(k) number is K171251.
When did 014 Hydrophilic Coated PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?
014 Hydrophilic Coated PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2017-09-08, under 510(k) number K171251.
Who is the listed applicant for 014 Hydrophilic Coated PTA Balloon Dilatation Catheter?
The FDA 510(k) record lists Creagh Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 014 Hydrophilic Coated PTA Balloon Dilatation Catheter?
The FDA product code for 014 Hydrophilic Coated PTA Balloon Dilatation 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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