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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 K111182
Model 109681-001
Device Name ANGIOJET SOLENT OMNI THROMBECTOMY SET
Original Applicant
MEDRAD, INC.
9055 evergreen blvd nw
minneapolis,  MN  55433 8003
Original Contact doug atkins
Regulation Number870.5150
Classification Product Code
DXE  
Subsequent Product Code
KRA  
Date Received04/27/2011
Decision Date 05/24/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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