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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K121385
Device Name VECTOR
Original Applicant
R4 VASCULAR, INC.
7550 meridian circle
suite 150
maple grove,  MN  55369
Original Contact michael hoch
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received05/08/2012
Decision Date 06/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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