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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
Model 7300V,7301V,7302V, 7304V, 7305V, 7326V, 7327V, 7342V, 7307V, 7324V, 7325V
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 Received09/12/2011
Decision Date 10/27/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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