K253092
- 510(k) number
- K253092
- Device name
- Argos Infinity (Rev. 1.0)
- Applicant
- Retia Medical Systems, Inc. NY · US
- Product code
- DXG — Computer, Diagnostic, Pre-Programmed, Single-Functio
- Decision date
- 2026-02-13
- Date received
- 2025-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K253092.pdf
Official FDA record: K253092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.