Salix Coronary Plaque (V1.0.0)— 510(k) K251837

Substantially Equivalent

Artrya Limited

FDA 510(k) clearance K251837 for Salix Coronary Plaque (V1.0.0), Substantially Equivalent on 2025-08-20. Applicant: Artrya Limited. Device class: 2.

Clearance details

Applicant: Artrya Limited
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-06-16
Decision date: 2025-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, AU

Download summary PDF View on FDA.gov ↗

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More clearances from Artrya Limited

K243038 — Salix Central2025-03-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.