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FDA 510(k)

EkoSonic Endovascular Device with Control Unit 4.0

K-Number: K183361 · 2019-04-05

ApplicantBtg International, Inc.
Decision Date2019-04-05
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EkoSonic Endovascular Device with Control Unit 4.0 is a medical device manufactured by Btg International, Inc.. It received FDA 510(k) clearance on 2019-04-05 under approval number K183361. 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 with Control Unit 4.0?

EkoSonic Endovascular Device with Control Unit 4.0 is a medical device that received FDA 510(k) clearance on 2019-04-05. It is manufactured by Btg International, Inc.. The 510(k) number is K183361.

When was EkoSonic Endovascular Device with Control Unit 4.0 approved by the FDA?

EkoSonic Endovascular Device with Control Unit 4.0 received FDA 510(k) clearance on 2019-04-05, under approval number K183361.

What company makes EkoSonic Endovascular Device with Control Unit 4.0?

EkoSonic Endovascular Device with Control Unit 4.0 is manufactured by Btg International, Inc..

What is the FDA product code for EkoSonic Endovascular Device with Control Unit 4.0?

The FDA product code for EkoSonic Endovascular Device with Control Unit 4.0 is QEY.

Related Clinical Trials

NCT05341661 Butterfly Pivotal Study ACTIVE_NOT_RECRUITING NCT04935697 Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress COMPLETED NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING 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 NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) 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)

Other Devices by Btg International, Inc.

K162771EkoSonic Endovascular System with Control Unit 4.0 K182324EkoSonic Endovascular System K172035EKOS ultrasound EVD Device, EVD Control Unit K191119EkoSonic Endovascular Device

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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