FDA 510(k)

FlexCath 過隔膜解決方案

K 號：K233691 · 2023-12-17

決定日期2023-12-17

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

FlexCath Cross Transseptal Solution is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2023-12-17 under 510(k) number K233691. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlexCath Cross Transseptal Solution?

FlexCath Cross Transseptal Solution is a medical device that received FDA 510(k) clearance on 2023-12-17. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K233691.

When did FlexCath Cross Transseptal Solution receive FDA 510(k) clearance?

FlexCath Cross Transseptal Solution received FDA 510(k) clearance on 2023-12-17, under 510(k) number K233691.

Who is the listed applicant for FlexCath Cross Transseptal Solution?

The FDA 510(k) record lists Acutus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlexCath Cross Transseptal Solution?

The FDA product code for FlexCath Cross Transseptal Solution is DYB.

其他以 Acutus Medical, Inc. 為申請人之記錄

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相關器械（代碼：DYB）

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