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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K122106
Models INS-0320, INS-0330, INS-0340, INS-0350, INS-0360, SYS-2000
Device Name SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
Original Applicant
VERAN MEDICAL TECHNOLOGIES, INC.
1908 innerbelt business center dr
saint louis,  MO  63114
Original Contact scott wrightstone
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/17/2012
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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