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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aspiration thrombectomy catheter
510(k) Number K113363
Device Name ANGIOJET SOLENT DISTA THROMBECTOMY SET
Applicant
MEDRAD, INC.
9055 EVERGREEN BLVD NW
MINNEAPOLIS,  MN  55433 -8003
Applicant Contact MIKE BURNSIDE
Correspondent
MEDRAD, INC.
9055 EVERGREEN BLVD NW
MINNEAPOLIS,  MN  55433 -8003
Correspondent Contact MIKE BURNSIDE
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received11/15/2011
Decision Date 06/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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