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 a medical device manufactured by Retia Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-02-13 under approval 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. It is manufactured by Retia Medical Systems, Inc.. The 510(k) number is K253092.
When was Argos Infinity (Rev. 1.0) approved by the FDA?
Argos Infinity (Rev. 1.0) received FDA 510(k) clearance on 2026-02-13, under approval number K253092.
What company makes Argos Infinity (Rev. 1.0)?
Argos Infinity (Rev. 1.0) is manufactured by Retia Medical Systems, Inc..
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)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.