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FDA 510(k)

ACIST CVi1 對比劑輸送系統，ACIST CVi 對比劑輸送系統

K 號：K203004 · 2020-12-17

申請人Acist Medical Systems, Inc.
決定日期2020-12-17
產品代碼DXT
諮詢委員會履歷
決定相當於

器材摘要

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery 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 2020-12-17 under 510(k) number K203004. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K203004.

When did ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System receive FDA 510(k) clearance?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System received FDA 510(k) clearance on 2020-12-17, under 510(k) number K203004.

Who is the listed applicant for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery 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 CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

The FDA product code for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is DXT.

相關臨床試驗

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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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相關器械（代碼：DXT）

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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