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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 K241550
Device Name Gelweave™ Vascular Prostheses
Applicant
Vascutek, Ltd.
Newmains Ave.
Inchinnan,  GB PA4 9RR
Applicant Contact Ryan King
Correspondent
Vascutek, Ltd.
Newmains Ave.
Inchinnan,  GB PA4 9RR
Correspondent Contact Ryan King
Regulation Number870.3450
Classification Product Code
DSY  
Date Received05/31/2024
Decision Date 02/27/2025
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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