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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 K122659
Device Name VDRIVE W/V-SONO
Original Applicant
STEREOTAXIS, INC.
4320 forest park avenue
suite 100
st. louis,  MO  63108
Original Contact horwitz
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXX  
Date Received08/31/2012
Decision Date 07/26/2013
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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