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FDA 510(k)

Salix Coronary Plaque (V1.0.0)

K-Number: K251837 · 2025-08-20

ApplicantArtrya Limited
Decision Date2025-08-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Salix Coronary Plaque (V1.0.0) is a medical device manufactured by Artrya Limited. It received FDA 510(k) clearance on 2025-08-20 under approval 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. It is manufactured by Artrya Limited. The 510(k) number is K251837.

When was Salix Coronary Plaque (V1.0.0) approved by the FDA?

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

What company makes Salix Coronary Plaque (V1.0.0)?

Salix Coronary Plaque (V1.0.0) is manufactured by Artrya Limited.

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.

Related Clinical Trials

NCT05755711 Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease ACTIVE_NOT_RECRUITING NCT07574411 Effects of E-care Protocol in Patients With Coronary Artery Bypass Graft NOT_YET_RECRUITING NCT06736899 Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions RECRUITING NCT06977295 Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study) RECRUITING NCT07515703 Plaque Modification and Drug Coated Balloons for Treatment of de Novo Calcific Coronary Lesions COMPLETED NCT07514988 Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment NOT_YET_RECRUITING

Other Devices by Artrya Limited

K243038Salix Central

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Official Source

View on FDA Database →

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

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