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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 K933987
Device Name AOR-TEX VASCULAR GRAFT
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 Received08/17/1993
Decision Date 05/17/1994
Decision SE SUBJECT TO TRACKING REG (ST)
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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