FDA 510(k)

EkoSonic Endovascular Device, EKOS+ Endovascular Device

K-Number: K213422 · 2021-12-14

Decision Date2021-12-14

Product CodeQEY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EkoSonic Endovascular Device, EKOS+ Endovascular Device is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-12-14 under approval number K213422. 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 EkoSonic Endovascular Device, EKOS+ Endovascular Device?

EkoSonic Endovascular Device, EKOS+ Endovascular Device is a medical device that received FDA 510(k) clearance on 2021-12-14. It is manufactured by Boston Scientific Corporation. The 510(k) number is K213422.

When was EkoSonic Endovascular Device, EKOS+ Endovascular Device approved by the FDA?

EkoSonic Endovascular Device, EKOS+ Endovascular Device received FDA 510(k) clearance on 2021-12-14, under approval number K213422.

What company makes EkoSonic Endovascular Device, EKOS+ Endovascular Device?

EkoSonic Endovascular Device, EKOS+ Endovascular Device is manufactured by Boston Scientific Corporation.

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

The FDA product code for EkoSonic Endovascular Device, 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 NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure 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 NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07065760 University of Utah PS-IDE: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms 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.