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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 K202703
Device Name Vascutek Gelsoft Plus ERS Vascular Graft
Applicant
Vascutek, Ltd.
Newmains Ave.
Inchinnan,  GB PA49RR
Applicant Contact Chirag Merchant
Correspondent
Vascutek, Ltd.
Newmains Ave.
Inchinnan,  GB PA49RR
Correspondent Contact Chirag Merchant
Regulation Number870.3450
Classification Product Code
DSY  
Date Received09/16/2020
Decision Date 04/06/2021
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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