FDA.report

510(k) K030999

Device
EPTFE VASCULAR PROSTHESIS; SEALPTFE
Applicant
VASCUTEK LTD.
510(k) number
K030999
Product code
DSY  
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-09
Date received
2003-03-31
Regulation
870.3450
Classification name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
STEVEN ARICK
Address
6200 Jackson Rd. Ann Arbor MI US 48103 48103

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
05037881007038SealPTFE™VASCUTEK LTD2015-10-19
05037881002002MAXIFLO™VASCUTEK LTD2015-10-19

Legacy Summary

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FDA Review

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