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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K072990
Device Name GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
Applicant
Medtronic, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact KAREN A BROZOWSKI
Correspondent
Medtronic, Inc.
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact KAREN A BROZOWSKI
Regulation Number870.1250
Classification Product Code
NTE  
Date Received10/24/2007
Decision Date 10/31/2007
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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