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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 K240083
Device Name GORE® PROPATEN® Vascular Graft
Applicant
W.L. Gore & Associates, Inc.
1505 N. Fourth St.
Phoenix,  AZ  86004
Applicant Contact Christine Snyder
Correspondent
W.L. Gore & Associates, Inc.
1505 N. Fourth St.
Phoenix,  AZ  86004
Correspondent Contact Christine Snyder
Regulation Number870.3450
Classification Product Code
DSY  
Date Received01/11/2024
Decision Date 03/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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