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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 K112571
Device Name XL EXTRACTION CATHETER
Original Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis,  MN  55369
Original Contact matt nienstedt
Regulation Number870.5150
Classification Product Code
DXE  
Date Received09/06/2011
Decision Date 10/06/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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