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FDA 510(k)

EKOS ultrasound EVD Device, EVD Control Unit

K-Number: K172035 · 2018-03-24

ApplicantBtg International, Inc.
Decision Date2018-03-24
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EKOS ultrasound EVD Device, EVD Control Unit 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 2018-03-24 under 510(k) number K172035. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKOS ultrasound EVD Device, EVD Control Unit?

EKOS ultrasound EVD Device, EVD Control Unit is a medical device that received FDA 510(k) clearance on 2018-03-24. The listed applicant is Btg International, Inc.. The 510(k) number is K172035.

When did EKOS ultrasound EVD Device, EVD Control Unit receive FDA 510(k) clearance?

EKOS ultrasound EVD Device, EVD Control Unit received FDA 510(k) clearance on 2018-03-24, under 510(k) number K172035.

Who is the listed applicant for EKOS ultrasound EVD Device, EVD Control Unit?

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 EKOS ultrasound EVD Device, EVD Control Unit?

The FDA product code for EKOS ultrasound EVD Device, EVD Control Unit is JXG.

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 4.0K182324EkoSonic Endovascular SystemK162771EkoSonic Endovascular System with Control Unit 4.0

Related Devices (Code: JXG)

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.

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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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