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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
510(k) Number K073563
Device Name MODIFICATION TO PROXIS SYSTEM
Applicant
St Jude Medical
6550 Wedgwood Rd. N.
Suite 150
Maple Grove,  MN  55311
Applicant Contact LINH PHAM
Correspondent
St Jude Medical
6550 Wedgwood Rd. N.
Suite 150
Maple Grove,  MN  55311
Correspondent Contact LINH PHAM
Regulation Number870.1250
Classification Product Code
NFA  
Date Received12/19/2007
Decision Date 01/31/2008
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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