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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 K081989
Device Name MODIFICATION TO FETCH ASPIRATION CATHETER
Applicant
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS,  MN  55433 -8003
Applicant Contact MIKE BURNSIDE
Correspondent
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS,  MN  55433 -8003
Correspondent Contact MIKE BURNSIDE
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received07/14/2008
Decision Date 09/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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