FDA 510(k)

Salix Coronary Plaque (V1.0.0)

K-Number: K251837 · 2025-08-20

Decision Date2025-08-20

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Salix Coronary Plaque (V1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Artrya Limited. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K251837. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Salix Coronary Plaque (V1.0.0)?

Salix Coronary Plaque (V1.0.0) is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Artrya Limited. The 510(k) number is K251837.

When did Salix Coronary Plaque (V1.0.0) receive FDA 510(k) clearance?

Salix Coronary Plaque (V1.0.0) received FDA 510(k) clearance on 2025-08-20, under 510(k) number K251837.

Who is the listed applicant for Salix Coronary Plaque (V1.0.0)?

The FDA 510(k) record lists Artrya Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Salix Coronary Plaque (V1.0.0)?

The FDA product code for Salix Coronary Plaque (V1.0.0) is QIH.

Other records listing Artrya Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243038Salix Central

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.