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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 K083300
Device Name GORE FLOW REVERSAL SYSTEM
Applicant
W. L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
Flagstaff,  AZ  86005
Applicant Contact MICHELLE A WELLS
Correspondent
W. L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
Flagstaff,  AZ  86005
Correspondent Contact MICHELLE A WELLS
Regulation Number870.1250
Classification Product Code
NTE  
Date Received11/10/2008
Decision Date 02/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00594100
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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