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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 K182324
Device Name EkoSonic Endovascular System
Applicant
Btg International, Inc.
11911 N. Creek Pkwy. S
Bothell,  WA  98011
Applicant Contact Benjamin Hornsey
Correspondent
Btg International, Inc.
11911 N. Creek Pkwy. S
Bothell,  WA  98011
Correspondent Contact Benjamin Hornsey
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received08/27/2018
Decision Date 11/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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