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FDA 510(k)

EkoSonic Endovascular System with Control Unit 4.0

K-Number: K162771 · 2017-02-24

ApplicantBtg International, Inc.
Decision Date2017-02-24
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EkoSonic Endovascular System with Control Unit 4.0 is a medical device manufactured by Btg International, Inc.. It received FDA 510(k) clearance on 2017-02-24 under approval number K162771. 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 with Control Unit 4.0?

EkoSonic Endovascular System with Control Unit 4.0 is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by Btg International, Inc.. The 510(k) number is K162771.

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

EkoSonic Endovascular System with Control Unit 4.0 received FDA 510(k) clearance on 2017-02-24, under approval number K162771.

What company makes EkoSonic Endovascular System with Control Unit 4.0?

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

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

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

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Related PubMed Literature

PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Btg International, Inc.

K182324EkoSonic Endovascular System 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. K170258SpeedLyser Infusion Catheter KitAngioDynamics, Inc. K182324EkoSonic Endovascular SystemBtg International, 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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