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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 K231972
Device Name Advanta VXT Vascular Graft, Flixene Vascular Graft
Applicant
Atrium Medical Corporation
40 Continental Blvd.
Merrimack,  NH  03054
Applicant Contact Hannah Scribner
Correspondent
Atrium Medical Corporation
40 Continental Blvd.
Merrimack,  NH  03054
Correspondent Contact Hannah Scribner
Regulation Number870.3450
Classification Product Code
DSY  
Subsequent Product Code
DYF  
Date Received07/03/2023
Decision Date 03/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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