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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, ultrasound, intravascular
510(k) Number K123813
Device Name VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE
Original Applicant
VASONOVA INC.
155 jefferson drive
suite 100
menlo park,  CA  94025
Original Contact christine ford
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received12/19/2012
Decision Date 01/18/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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