FDA.report

510(k) K952293

Device
VASCUTEK GELWEAVE VASCULAR GRAFT
Applicant
VASCUTEK LTD.
510(k) number
K952293
Product code
DSY  
Decision
Se Subject To Tracking Reg (ST)
Decision date
1995-12-19
Date received
1995-05-16
Regulation
870.3450
Classification name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
TEENA M AUGOSTINO
Address
1300-A E. Anderson Ln. Austin TX US 78752 78752

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
05037881018171Gelweave™VASCUTEK LTD2015-10-19
05037881018140Gelweave™VASCUTEK LTD2015-10-19
05037881018119Gelweave™VASCUTEK LTD2015-10-19
05037881018102Gelweave™VASCUTEK LTD2015-10-19
05037881018089Gelweave™VASCUTEK LTD2015-10-19
05037881018072Gelweave™VASCUTEK LTD2015-10-19
05037881018065Gelweave™VASCUTEK LTD2015-10-19
05037881007922Gelweave™VASCUTEK LTD2015-10-19
05037881002286Gelweave™VASCUTEK LTD2015-10-19

Legacy Summary

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FDA Review

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