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FDA 510(k)

EkoSonic Endovascular Device

K-Number: K191119 · 2019-08-23

ApplicantBtg International, Inc.
Decision Date2019-08-23
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EkoSonic Endovascular Device is a medical device manufactured by Btg International, Inc.. It received FDA 510(k) clearance on 2019-08-23 under approval number K191119. 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?

EkoSonic Endovascular Device is a medical device that received FDA 510(k) clearance on 2019-08-23. It is manufactured by Btg International, Inc.. The 510(k) number is K191119.

When was EkoSonic Endovascular Device approved by the FDA?

EkoSonic Endovascular Device received FDA 510(k) clearance on 2019-08-23, under approval number K191119.

What company makes EkoSonic Endovascular Device?

EkoSonic Endovascular Device is manufactured by Btg International, Inc..

What is the FDA product code for EkoSonic Endovascular Device?

The FDA product code for EkoSonic 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 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 NCT02266719 Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024) PMID: 41583580 Postmarket Surveillance of Neuroendovascular Devices. Stroke (Hoboken, N.J.) (2024) PMID: 28216355 Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection. Journal of vascular surgery (2017)

Other Devices by Btg International, Inc.

K162771EkoSonic Endovascular System with Control Unit 4.0 K182324EkoSonic Endovascular System K172035EKOS ultrasound EVD Device, EVD Control Unit K183361EkoSonic Endovascular Device with Control Unit 4.0

Related Devices (Code: QEY)

K162777Squirt Fluid Delivery SystemMerit Medical Systems, Inc. K153488Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. K163356Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc. K162771EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. K170258SpeedLyser Infusion Catheter KitAngioDynamics, Inc. K182324EkoSonic Endovascular SystemBtg International, Inc.

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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