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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 K073700
Device Name 6F PROXIS SYSTEM
Applicant
St. Jude Medical, Inc.
6500 Wedgwood Rd. N.
Maple Grove,  MN  55311
Applicant Contact LINH PHAM
Correspondent
St. Jude Medical, Inc.
6500 Wedgwood Rd. N.
Maple Grove,  MN  55311
Correspondent Contact LINH PHAM
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/31/2007
Decision Date 10/02/2008
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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