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FDA 510(k)

Argos Infinity (Rev. 1.0)

K-Number: K253092 · 2026-02-13

ApplicantRetia Medical Systems, Inc.
Decision Date2026-02-13
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: DXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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