Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Btg International, Inc.. It received FDA 510(k) clearance on 2019-04-05 under 510(k) 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. The listed applicant is Btg International, Inc.. The 510(k) number is K183361.

When did EkoSonic Endovascular Device with Control Unit 4.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for EkoSonic Endovascular Device with Control Unit 4.0?

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 Device with Control Unit 4.0?

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

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 DeviceK182324EkoSonic Endovascular SystemK172035EKOS 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

View on FDA Database →

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

↑