VASCUTEK GELWEAVE 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 Gelweave Vascular Graft.

Pre-market Notification Details

Device IDK952293
510k NumberK952293
Device Name:VASCUTEK GELWEAVE VASCULAR GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant VASCUTEK LTD. 1300-A EAST ANDERSON LN. Austin,  TX  78752 -1793
ContactTeena M Augostino
CorrespondentTeena M Augostino
VASCUTEK LTD. 1300-A EAST ANDERSON LN. Austin,  TX  78752 -1793
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-16
Decision Date1995-12-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05037881018171 K952293 000
05037881018140 K952293 000
05037881018119 K952293 000
05037881018102 K952293 000
05037881018089 K952293 000
05037881018072 K952293 000
05037881018065 K952293 000
05037881007922 K952293 000
05037881002286 K952293 000

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