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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Thrombolysis Catheter
510(k) Number K140151
Device Name EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
Applicant
BTG INTERNATIONAL, INC.
11911 NORTH CREEK PARKWAY S
BOTHELL,  WA  98011
Applicant Contact JOCELYN KERSTEN
Correspondent
BTG INTERNATIONAL, INC.
11911 NORTH CREEK PARKWAY S
BOTHELL,  WA  98011
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received01/22/2014
Decision Date 05/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Clinical Trials NCT01166997
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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