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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 K081467
Device Name EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
Applicant
EKOS CORP.
11911 N CREEK PARKWAY SOUTH
BOTHELL,  WA  98011
Applicant Contact JOCELYN KERSTEN
Correspondent
EKOS CORP.
11911 N CREEK PARKWAY SOUTH
BOTHELL,  WA  98011
Correspondent Contact JOCELYN KERSTEN
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received05/27/2008
Decision Date 06/26/2008
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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