Argos Infinity (Rev. 1.0)— 510(k) K253092

Name: FDA 510(k) clearance K253092
Creator: U.S. Food and Drug Administration
Published: 2026-02-13

Substantially Equivalent

Retia Medical Systems, Inc.

FDA 510(k) clearance K253092 for Argos Infinity (Rev. 1.0), Substantially Equivalent on 2026-02-13. Applicant: Retia Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Retia Medical Systems, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2025-09-23
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

Download summary PDF View on FDA.gov ↗

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