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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 K073523
Device Name INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
Applicant
Medtronic, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact COLLEEN MULLINS
Correspondent
Medtronic, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact COLLEEN MULLINS
Regulation Number870.1250
Classification Product Code
NFA  
Date Received12/14/2007
Decision Date 08/01/2008
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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