Artrya Limited
AU Last updated 22 Oct 2026
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- Devices
- 2
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Salix Coronary Plaque (V1.0.0) Ref K251837
Salix Central Ref K243038
FDA establishments
- Artrya Perth Western Australia · AU FEI 3017233423
What Artrya Limited makes
Artrya Limited manufactures intravascular imaging devices, including the Salix Coronary Plaque system for visualizing atherosclerotic plaque within coronary arteries and the Salix Central system for assessing central arterial plaque composition.
These devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. The company is based in the United States.
Frequently asked questions
What types of medical devices does Artrya Limited manufacture?
Artrya Limited specializes in intravascular imaging devices. Specifically, they produce systems like the Salix Coronary Plaque (V1.0.0), designed to visualize atherosclerotic plaque within coronary arteries, and the Salix Central, which assesses plaque composition in central arteries. These devices help clinicians evaluate arterial health and guide treatment decisions.
Where is Artrya Limited based?
Artrya Limited is headquartered in the United States. The company’s location is relevant for regulatory oversight, manufacturing operations, and compliance with U.S. medical device regulations.
How are Artrya Limited’s devices classified under FDA regulations?
Artrya Limited’s devices, such as the Salix Coronary Plaque and Salix Central systems, are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Are Artrya Limited’s devices listed in any regulatory registries?
Yes, Artrya Limited’s devices are included in the FDA’s 510(k) clearance registry. This registry tracks devices that have undergone a 510(k) premarket notification process, demonstrating that they are substantially equivalent to legally marketed predicate devices. Listing here indicates compliance with FDA requirements for market authorization.
Information
- Country
- AU