FDA.report

510(k) K070323

Device
TEMPORARY LIMB SALVAGE SHUNT
Applicant
VASCUTEK LTD.
510(k) number
K070323
Product code
DXC  
Decision
Substantially Equivalent (SESE)
Decision date
2007-02-15
Date received
2007-02-02
Regulation
870.4450
Classification name
Clamp, Vascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Expedited review
Y
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

Legacy Summary

summary

FDA Review

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