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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K070417
Device Name ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact Laura Moen-Ftacek
Correspondent
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact Laura Moen-Ftacek
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/12/2007
Decision Date 06/05/2007
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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