FDA 510(k)

ACIST Kodama 静脈內超聲波針，ACIST HDi 系統

K 號：K191175 · 2019-06-27

決定日期2019-06-27

產品代碼OBJ

諮詢委員會履歷

決定相當於

器材摘要

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-06-27 under 510(k) number K191175. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

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 2019-06-27. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K191175.

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 2019-06-27, under 510(k) number K191175.

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.

其他以 Acist Medical Systems, Inc. 為申請人之記錄

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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。

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