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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 K142235
Device Name CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
Applicant
St Jude Medical
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact ZACHARY PRICE
Correspondent
St Jude Medical
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact ZACHARY PRICE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/13/2014
Decision Date 12/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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