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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 K090613
Device Name CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2
Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact COLLEEN CANAN
Correspondent
St. Jude Medical, Cardiac Rhythm Management Divisi
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact COLLEEN CANAN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/06/2009
Decision Date 07/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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