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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
Recalls CDRH Recalls
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