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FDA 510(k)

EKOS+ Endovascular Device

K-Number: K220866 · 2022-04-20

ApplicantBoston Scientific
Decision Date2022-04-20
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKOS+ Endovascular Device is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2022-04-20 under approval number K220866. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKOS+ Endovascular Device?

EKOS+ Endovascular Device is a medical device that received FDA 510(k) clearance on 2022-04-20. It is manufactured by Boston Scientific. The 510(k) number is K220866.

When was EKOS+ Endovascular Device approved by the FDA?

EKOS+ Endovascular Device received FDA 510(k) clearance on 2022-04-20, under approval number K220866.

What company makes EKOS+ Endovascular Device?

EKOS+ Endovascular Device is manufactured by Boston Scientific.

What is the FDA product code for EKOS+ Endovascular Device?

The FDA product code for EKOS+ Endovascular Device is QEY.

Related Clinical Trials

NCT06872905 Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT05501873 Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System ACTIVE_NOT_RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT04674969 Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature 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)

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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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