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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 K111182
Device Name ANGIOJET SOLENT OMNI THROMBECTOMY SET
Applicant
MEDRAD, INC.
9055 EVERGREEN BLVD NW
MINNEAPOLIS,  MN  55433 -8003
Applicant Contact Doug Atkins
Correspondent
MEDRAD, INC.
9055 EVERGREEN BLVD NW
MINNEAPOLIS,  MN  55433 -8003
Correspondent Contact Doug Atkins
Regulation Number870.5150
Classification Product Code
QEZ  
Subsequent Product Code
KRA  
Date Received04/27/2011
Decision Date 05/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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