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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 K072507
Device Name ENDOWAVE INFUSION SYSTEM
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 Received09/06/2007
Decision Date 10/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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