ACIST Kodama 静脈內超聲波針，ACIST HDi 系統
K 號：K173063 · 2017-10-23
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器材摘要
常見問題
What is the ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K173063.
When did ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System receive FDA 510(k) clearance?
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System received FDA 510(k) clearance on 2017-10-23, under 510(k) number K173063.
Who is the listed applicant for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?
The FDA 510(k) record lists Acist Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?
The FDA product code for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is OBJ.
相關臨床試驗
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其他以 Acist Medical Systems, Inc. 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。
相關器械（代碼：OBJ）
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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