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FDA 510(k)

EkoSonic Endovascular System

K-Number: K182324 · 2018-11-26

ApplicantBtg International, Inc.
Decision Date2018-11-26
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EkoSonic Endovascular System is a medical device manufactured by Btg International, Inc.. It received FDA 510(k) clearance on 2018-11-26 under approval number K182324. 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 System?

EkoSonic Endovascular System is a medical device that received FDA 510(k) clearance on 2018-11-26. It is manufactured by Btg International, Inc.. The 510(k) number is K182324.

When was EkoSonic Endovascular System approved by the FDA?

EkoSonic Endovascular System received FDA 510(k) clearance on 2018-11-26, under approval number K182324.

What company makes EkoSonic Endovascular System?

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

What is the FDA product code for EkoSonic Endovascular System?

The FDA product code for EkoSonic Endovascular System is QEY.

Related Clinical Trials

NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT06710938 Thoracoabdominal Artery Stent Graft System Exploratory Study RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT03298477 EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study COMPLETED NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

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: 29988408 Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke. Frontiers in neurology (2018)

Other Devices by Btg International, Inc.

K162771EkoSonic Endovascular System with Control Unit 4.0 K172035EKOS ultrasound EVD Device, EVD Control Unit K191119EkoSonic Endovascular Device 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. K193071Bashir Plus Endovascular CatheterThrombolex, 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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