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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K093858
Device Name PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact Beena Flynn
Correspondent
St. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact Beena Flynn
Regulation Number870.2900
Classification Product Code
DSA  
Subsequent Product Code
DTA  
Date Received12/16/2009
Decision Date 04/02/2010
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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