Argos Infinity (Rev. 1.0)— 510(k) K253092
Substantially EquivalentRetia 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.
Summary
Retia Medical Systems' Argos Infinity (Rev. 1.0) is filed under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 870.1435. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Retia Medical Systems filed from White Plains, New York. FDA found it substantially equivalent 143 calendar days after receipt (September 23, 2025 to February 13, 2026).
Clearance details
- Applicant
- Retia Medical Systems, Inc.
- Product code
- Product code DXG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1435
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- White Plains, NY, US
Recent devices under product code DXG
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