FDA 510(k)

精密TAVI (v1.1)

K 號：K223809 · 2023-05-30

決定日期2023-05-30

產品代碼QQI

諮詢委員會履歷

決定相當於

器材摘要

PrecisionTAVI (v1.1) is the device name listed in this FDA 510(k) record. The listed applicant is Dasi Simulations. It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K223809. The device is classified under product code QQI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PrecisionTAVI (v1.1)?

PrecisionTAVI (v1.1) is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Dasi Simulations. The 510(k) number is K223809.

When did PrecisionTAVI (v1.1) receive FDA 510(k) clearance?

PrecisionTAVI (v1.1) received FDA 510(k) clearance on 2023-05-30, under 510(k) number K223809.

Who is the listed applicant for PrecisionTAVI (v1.1)?

The FDA 510(k) record lists Dasi Simulations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PrecisionTAVI (v1.1)?

The FDA product code for PrecisionTAVI (v1.1) is QQI.

其他以 Dasi Simulations 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。

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相關器械（代碼：QQI）

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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