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.

Clearance details

Applicant: Artrya Limited
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-06-16
Decision date: 2025-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perth, AU

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