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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wire, guide, catheter
510(k) Number K112631
Device Name VSI GUIDEWIRE
Original Applicant
VASCULAR SOLUTIONS, INC.
6464 sycamore court north
minneapolis,  MN  55369
Original Contact melinda swanson
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/09/2011
Decision Date 10/27/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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