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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 K183361
Device Name EkoSonic Endovascular Device with Control Unit 4.0
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 Received12/04/2018
Decision Date 04/05/2019
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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