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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K941981
Device Name AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
Applicant
W. L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
P.O. Box 2400
Flagstaff,  AZ  86001
Applicant Contact VICKI LEWIS
Correspondent
W. L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
P.O. Box 2400
Flagstaff,  AZ  86001
Correspondent Contact VICKI LEWIS
Regulation Number870.3450
Classification Product Code
DSY  
Date Received04/14/1994
Decision Date 07/20/1994
Decision SE SUBJECT TO TRAKING & PMS (PT)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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