Vascutek Gelsoft Plus ERS Vascular Graft

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Vascutek Ltd

The following data is part of a premarket notification filed by Vascutek Ltd with the FDA for Vascutek Gelsoft Plus Ers Vascular Graft.

Pre-market Notification Details

Device IDK202703
510k NumberK202703
Device Name:Vascutek Gelsoft Plus ERS Vascular Graft
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant Vascutek Ltd Newmains Avenue Inchinnan,  GB Pa4 9rr
ContactChirag Merchant
CorrespondentChirag Merchant
Vascutek Ltd Newmains Avenue Inchinnan,  GB Pa4 9rr
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-16
Decision Date2021-04-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05037881115832 K202703 000
05037881115825 K202703 000

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