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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 the device name listed in this FDA 510(k) record. The listed applicant is Btg International, Inc.. It received FDA 510(k) clearance on 2018-11-26 under 510(k) 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. The listed applicant is Btg International, Inc.. The 510(k) number is K182324.

When did EkoSonic Endovascular System receive FDA 510(k) clearance?

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

Who is the listed applicant for EkoSonic Endovascular System?

The FDA 510(k) record lists Btg International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EkoSonic Endovascular System?

The FDA product code for EkoSonic Endovascular System is QEY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06819865A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary EmbolismRECRUITING

Other records listing Btg International, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191119EkoSonic Endovascular DeviceK183361EkoSonic Endovascular Device with Control Unit 4.0K172035EKOS ultrasound EVD Device, EVD Control UnitK162771EkoSonic Endovascular System with Control Unit 4.0

Related Devices (Code: QEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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