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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 K013913
Device Name PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
Applicant
Medtronic Percusurge, Inc.
530 Mercury Dr.
Sunnyvale,  CA  94085
Applicant Contact MATTHEW J MOON
Correspondent
Medtronic Percusurge, Inc.
530 Mercury Dr.
Sunnyvale,  CA  94085
Correspondent Contact MATTHEW J MOON
Regulation Number870.1250
Classification Product Code
NFA  
Date Received11/27/2001
Decision Date 11/15/2002
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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