FDA.report

510(k) K081560

Device
VASCUTEK CANNULA GRAFT, MODEL CGS2008S
Applicant
VASCUTEK LTD.
510(k) number
K081560
Product code
DWF  
Decision
Substantially Equivalent (SESE)
Decision date
2009-02-10
Date received
2008-06-03
Regulation
870.4210
Classification name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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

Related GUDID Devices

Primary DIBrandCompanyPublished
05037881009537Cannula Graft™VASCUTEK LTD2015-10-24

Legacy Summary

summary

FDA Review

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