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FDA 510(k)

Argos Infinity (修訂版 1.0)

K 號:K253092 · 2026-02-13

決定日期2026-02-13
產品代碼DXG
諮詢委員會履歷
決定相當於

器材摘要

Argos Infinity (Rev. 1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Retia Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K253092. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Argos Infinity (Rev. 1.0)?

Argos Infinity (Rev. 1.0) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Retia Medical Systems, Inc.. The 510(k) number is K253092.

When did Argos Infinity (Rev. 1.0) receive FDA 510(k) clearance?

Argos Infinity (Rev. 1.0) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K253092.

Who is the listed applicant for Argos Infinity (Rev. 1.0)?

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

What is the FDA product code for Argos Infinity (Rev. 1.0)?

The FDA product code for Argos Infinity (Rev. 1.0) is DXG.

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相關器械(代碼:DXG)

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。

官方來源

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