Argos Infinity (Rev. 1.0)

Argos Infinity (Rev. 1.0) is an FDA 510(k)-cleared medical device (K253092) manufactured by Retia Medical Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 2026. Regulation: 8.