SureFlo EVD 尿管
K 號：K170599 · 2017-08-31
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器材摘要
SureFlo EVD Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Arkis Biosciences, Inc.. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K170599. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SureFlo EVD Catheter?
SureFlo EVD Catheter is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Arkis Biosciences, Inc.. The 510(k) number is K170599.
When did SureFlo EVD Catheter receive FDA 510(k) clearance?
SureFlo EVD Catheter received FDA 510(k) clearance on 2017-08-31, under 510(k) number K170599.
Who is the listed applicant for SureFlo EVD Catheter?
The FDA 510(k) record lists Arkis Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SureFlo EVD Catheter?
The FDA product code for SureFlo EVD Catheter is JXG.
相關臨床試驗
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相關器械（代碼：JXG）
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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