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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 K082382
Device Name ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
Applicant
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS,  MN  55433 -8003
Applicant Contact MARK STENOIEN
Correspondent
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS,  MN  55433 -8003
Correspondent Contact MARK STENOIEN
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received08/19/2008
Decision Date 12/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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