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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 K053277
Device Name CPS DIRECT SL OUTER CATHETER
Applicant
St Jude Medical
15900 Valley View Ct.
Sylmar,  CA  91342 -3577
Applicant Contact DEANNA HUGHES
Correspondent
St Jude Medical
15900 Valley View Ct.
Sylmar,  CA  91342 -3577
Correspondent Contact DEANNA HUGHES
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/23/2005
Decision Date 02/24/2006
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
Recalls CDRH Recalls
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