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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K121381
Device Name VIEWFLEX XTRA ICE CATHETER
Original Applicant
ST. JUDE MEDICAL
one st. jude medical drive
st. paul,  MN  55117
Original Contact loucinda bjorklund
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/08/2012
Decision Date 06/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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