K182324

Substantially Equivalent

EkoSonic Endovascular System

Applicant: Btg International, Inc.
Product code: QEY
Advisory panel: Cardiovascular
Date received: 2018-08-27
Decision date: 2018-11-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.