EkoSonic Endovascular Device— 510(k) K191119

Substantially Equivalent

Btg International, Inc.

FDA 510(k) clearance K191119 for EkoSonic Endovascular Device, Substantially Equivalent on 2019-08-23. Applicant: Btg International, Inc..

Clearance details

Applicant: Btg International, Inc.
Product code: Code QEY
Advisory panel: Cardiovascular
Date received: 2019-04-26
Decision date: 2019-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

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