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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 K200648
Device Name EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
Applicant
Ekos Corporation
11911 N. Creek Pkwy. S
Bothell,  WA  98011
Applicant Contact Joshua Kim
Correspondent
Ekos Corporation
11911 N. Creek Pkwy. S
Bothell,  WA  98011
Correspondent Contact Joshua Kim
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received03/12/2020
Decision Date 08/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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