K-number	K183361
Device name	EkoSonic Endovascular Device with Control Unit 4.0
Applicant	Btg International, Inc.
Product code	QEY
Device class	Class II
Decision date	Apr 5, 2019
Decision	Substantially Equivalent
Regulation	870.5150

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Source

View the full FDA submission: accessdata.fda.gov

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EkoSonic Endovascular Device with Control Unit 4.0

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