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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K120296
Model DS2M021, DS2M022, DS2M023
Device Name CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
Original Applicant
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar,  CA  91342
Original Contact colleen canan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/31/2012
Decision Date 05/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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