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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 K233551
Device Name GORE® ACUSEAL 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  
Subsequent Product Code
DYF  
Date Received11/03/2023
Decision Date 12/19/2023
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
Recalls CDRH Recalls
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