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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 K162771
Device Name EkoSonic Endovascular System with Control Unit 4.0
Applicant
Btg International, Inc.
11911 N. Creek Pkwy. S
Bothell,  WA  98011
Applicant Contact CURTIS JENSEN
Correspondent
Btg International, Inc.
11911 N. Creek Pkwy. S
Bothell,  WA  98011
Correspondent Contact CURTIS JENSEN
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received10/03/2016
Decision Date 02/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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