Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Solus Gold Embolization Device

K-Number: K213200 · 2022-03-21

ApplicantArtio Medical, Inc.
Decision Date2022-03-21
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Solus Gold Embolization Device is a medical device manufactured by Artio Medical, Inc.. It received FDA 510(k) clearance on 2022-03-21 under approval number K213200. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solus Gold Embolization Device?

Solus Gold Embolization Device is a medical device that received FDA 510(k) clearance on 2022-03-21. It is manufactured by Artio Medical, Inc.. The 510(k) number is K213200.

When was Solus Gold Embolization Device approved by the FDA?

Solus Gold Embolization Device received FDA 510(k) clearance on 2022-03-21, under approval number K213200.

What company makes Solus Gold Embolization Device?

Solus Gold Embolization Device is manufactured by Artio Medical, Inc..

What is the FDA product code for Solus Gold Embolization Device?

The FDA product code for Solus Gold Embolization Device is KRD.

Related Clinical Trials

NCT06604884 NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study RECRUITING NCT04289480 Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms ACTIVE_NOT_RECRUITING NCT07477860 Achilles Tendinopathy Embolization RECRUITING NCT06453642 Evaluation of a Simple-Prep Controlled Embolic ACTIVE_NOT_RECRUITING NCT04057352 Citadel Embolization Device Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41112966 Vascular Reconstruction Device for Coil Embolization of Wide-Neck Type Cerebral Aneurysm: Findings from a Post-Marketing Surveillance Study in Japan. Journal of neuroendovascular therapy (2025)

Related Devices (Code: KRD)

K162373LC Bead LUMIBiocompatibles UK Limited K160219Hilal Embolization MicroCoilsCook Incorporated K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated K150876Bead BlockBiocompatibles UK , Ltd. K171946Gel-BeadVascular Solutions, Inc. K172372QuadraSphere MicrospheresBiosphere Medical, S.A.

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.

↑