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FDA 510(k)

ACIST RXi 系統 (016616)；ACIST Navvus II 針 (016675_)

K 號：K233904 · 2024-07-17

申請人Acist Medical Systems, Inc.
決定日期2024-07-17
產品代碼DXO
諮詢委員會履歷
決定相當於

器材摘要

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ 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 2024-07-17 under 510(k) number K233904. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is a medical device that received FDA 510(k) clearance on 2024-07-17. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K233904.

When did ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ receive FDA 510(k) clearance?

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ received FDA 510(k) clearance on 2024-07-17, under 510(k) number K233904.

Who is the listed applicant for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

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 RXi System (016616); ACIST Navvus II Catheter (016675_?

The FDA product code for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is DXO.

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：DXO）

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

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