EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT— 510(k) K140151

Substantially Equivalent

Btg International, Inc.

FDA 510(k) clearance K140151 for EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT, Substantially Equivalent on 2014-05-21. Applicant: Btg International, Inc..

Clearance details

Applicant: Btg International, Inc.
Product code: Code QEY
Advisory panel: Cardiovascular
Date received: 2014-01-22
Decision date: 2014-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

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