FDA 510(k)

ACIST HDi 系統，ACIST Kodama 靜脈內超聲波針

K 號：K193183 · 2020-03-20

決定日期2020-03-20

產品代碼OBJ

諮詢委員會履歷

決定相當於

器材摘要

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter 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 2020-03-20 under 510(k) number K193183. 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 HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K193183.

When did ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter receive FDA 510(k) clearance?

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193183.

Who is the listed applicant for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

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 HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

The FDA product code for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter 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）

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