FDA.report

510(k) K091778

Device
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
Applicant
VASCUTEK LTD.
510(k) number
K091778
Product code
DSY  
Decision
Substantially Equivalent (SESE)
Decision date
2009-08-31
Date received
2009-06-17
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
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
KAREN KELSO
Address
Newmains Ave. Inchinnan Industrial Estate Renfrewshire, Glasgow GB PA4 9RR PA4 9RR

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

summary

FDA Review

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