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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 K191119
Device Name EkoSonic Endovascular Device
Applicant
BTG International, Inc.
11911 North Creek Parkway S
Bothell,  WA  98011
Applicant Contact Joshua Kim
Correspondent
BTG International, Inc.
11911 North Creek Parkway S
Bothell,  WA  98011
Correspondent Contact Joshua Kim
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received04/26/2019
Decision Date 08/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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