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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 K101354
Device Name FETCH 2 ASPIRATION CATHETER MODEL 109400-001
Applicant
MEDRAD INTERVENTIONAL/POSSIS
9055 EVERGREEN BLVD NW
minneapolis,  MN  55433
Applicant Contact doug atkins
Correspondent
MEDRAD INTERVENTIONAL/POSSIS
9055 EVERGREEN BLVD NW
minneapolis,  MN  55433
Correspondent Contact doug atkins
Regulation Number870.5150
Classification Product Code
DXE  
Date Received05/14/2010
Decision Date 01/21/2011
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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