FDA 510(k)

Argos Infinity (Rev. 1.0)

Número K: K253092 · 2026-02-13

Data da decisão2026-02-13

Código do produtoDXG

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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