FDA.report

510(k) K964959

Device
VASCUTEK TWILLWEAVE VASCULAR GRAFT
Applicant
VASCUTEK LTD.
510(k) number
K964959
Product code
DSY  
Decision
Se Subject To Tracking Reg (ST)
Decision date
1997-03-10
Date received
1996-12-11
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 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
05037881125459Twillweave™VASCUTEK LTD2015-10-19
05037881125015Twillweave™VASCUTEK LTD2015-10-19
05037881125022Twillweave™VASCUTEK LTD2015-10-19
05037881125039Twillweave™VASCUTEK LTD2015-10-19
05037881125046Twillweave™VASCUTEK LTD2015-10-19
05037881125053Twillweave™VASCUTEK LTD2015-10-19
05037881125060Twillweave™VASCUTEK LTD2015-10-19
05037881125183Twillweave™VASCUTEK LTD2015-10-19
05037881125190Twillweave™VASCUTEK LTD2015-10-19
05037881125206Twillweave™VASCUTEK LTD2015-10-19
05037881125213Twillweave™VASCUTEK LTD2015-10-19
05037881125275Twillweave™VASCUTEK LTD2015-10-19
05037881125282Twillweave™VASCUTEK LTD2015-10-19
05037881125442Twillweave™VASCUTEK LTD2015-10-19
05037881126159Twillweave™VASCUTEK LTD2015-10-19
05037881125565Twillweave™VASCUTEK LTD2015-10-19
05037881125572Twillweave™VASCUTEK LTD2015-10-19
05037881125589Twillweave™VASCUTEK LTD2015-10-19
05037881125596Twillweave™VASCUTEK LTD2015-10-19
05037881125657Twillweave™VASCUTEK LTD2015-10-19
05037881125664Twillweave™VASCUTEK LTD2015-10-19
05037881125671Twillweave™VASCUTEK LTD2015-10-19
05037881125688Twillweave™VASCUTEK LTD2015-10-19
05037881125695Twillweave™VASCUTEK LTD2015-10-19
05037881125701Twillweave™VASCUTEK LTD2015-10-19
05037881125718Twillweave™VASCUTEK LTD2015-10-19
05037881126111Twillweave™VASCUTEK LTD2015-10-19

Legacy Summary

summary

FDA Review

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