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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
Model WV0613502 AND WV0713502
Device Name CLEARLUMEN THROMBECTOMY SYSTEM
Applicant
WALK VASCULAR LLC
17171 daimler st
irvine,  CA  92614
Contact david look
Regulation Number870.5150
Classification Product Code
DXE  
Date Received02/21/2012
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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