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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 K113363
Model 11303-001
Device Name ANGIOJET SOLENT DISTA THROMBECTOMY SET
Original Applicant
MEDRAD, INC.
9055 evergreen blvd nw
minneapolis,  MN  55433 8003
Original Contact mike burnside
Regulation Number870.5150
Classification Product Code
DXE  
Date Received11/15/2011
Decision Date 06/06/2012
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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