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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, embolectomy
510(k) Number K120508
Device Name CLEARLUMEN THROMBECTOMY SYSTEM
Original Applicant
WALK VASCULAR LLC
17171 daimler st
irvine,  CA  92614
Original Contact david look
Regulation Number870.5150
Classification Product Code
DXE  
Date Received02/21/2012
Decision Date 11/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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