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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 K241070
Device Name Gelsoft™ Plus Vascular Prostheses
Applicant
Vascutek, Ltd.
Newmains Ave.
Inchinnan
Renfrewshire,  GB PA49RR
Applicant Contact Ryan King
Correspondent
Vascutek, Ltd.
Newmains Ave.
Inchinnan
Renfrewshire,  GB PA49RR
Correspondent Contact King Ryan
Regulation Number870.3450
Classification Product Code
DSY  
Date Received04/19/2024
Decision Date 11/15/2024
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
Recalls CDRH Recalls
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