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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K122587
Device Name BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact HARLAN JONES
Correspondent
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact HARLAN JONES
Regulation Number870.1390
Classification Product Code
DRC  
Date Received08/24/2012
Decision Date 02/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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