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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 K052071
Device Name LYSUS INFUSION SYSTEM
Applicant
Ekos Corp.
22030 20th Ave. SE
Suite 101
Bothell,  WA  98021
Applicant Contact JOCELYN KERSTEN
Correspondent
Ekos Corp.
22030 20th Ave. SE
Suite 101
Bothell,  WA  98021
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received08/01/2005
Decision Date 08/16/2005
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
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