愛德華氣球導管
K 號：K153069 · 2016-01-07
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器材摘要
Edwards Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K153069. The device is classified under product code OMZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Edwards Balloon Catheter?
Edwards Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Edwards Lifesciences. The 510(k) number is K153069.
When did Edwards Balloon Catheter receive FDA 510(k) clearance?
Edwards Balloon Catheter received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153069.
Who is the listed applicant for Edwards Balloon Catheter?
The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Edwards Balloon Catheter?
The FDA product code for Edwards Balloon Catheter is OMZ.
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其他以 Edwards Lifesciences 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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