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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
510(k) Number K003446
Device Name SYMMETRY AORTIC CLIP SYSTEM
Applicant
St. Jude Medical Cardiovascular Group, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact ROBERT L SHERIDAN
Correspondent
St. Jude Medical Cardiovascular Group, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact ROBERT L SHERIDAN
Regulation Number878.4300
Classification Product Code
NCA  
Date Received11/06/2000
Decision Date 05/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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