FDA.report

510(k) K200955

Device
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
Applicant
Vascutek Ltd
510(k) number
K200955
Product code
DXZ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-08
Date received
2020-04-09
Regulation
870.3470
Classification name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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
Heidi Forsyth
Address
Newmains Ave. Inchinnan GB PA49RR PA49RR

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
05037881010649Gelsoft™ Cardiovascular PatchVASCUTEK LTD2020-07-16
05037881010663Gelsoft™ Cardiovascular PatchVASCUTEK LTD2020-07-16
05037881010465Gelseal™VASCUTEK LTD2019-02-18
05037881010434Gelseal™ Cardiovascular PatchVASCUTEK LTD2019-02-16
05037881010618Gelsoft™ Cardiovascular PatchVASCUTEK LTD2019-02-16
05037881010670Gelsoft™VASCUTEK LTD2015-10-22
05037881010410Gelseal™VASCUTEK LTD2015-10-22
05037881010427Gelseal™VASCUTEK LTD2015-10-22
05037881010441Gelseal™VASCUTEK LTD2015-10-22
05037881010458Gelseal™VASCUTEK LTD2015-10-22
05037881010625Gelsoft™VASCUTEK LTD2015-10-22
05037881010632Gelsoft™VASCUTEK LTD2015-10-22
05037881010656Gelsoft™VASCUTEK LTD2015-10-22
05037881010892ThinwallVASCUTEK LTD2015-10-22
05037881010687Gelsoft™VASCUTEK LTD2015-10-22
05037881010694Gelsoft™VASCUTEK LTD2015-10-22
05037881010700Gelsoft™VASCUTEK LTD2015-10-22
05037881010816ThinwallVASCUTEK LTD2015-10-22
05037881010823ThinwallVASCUTEK LTD2015-10-22
05037881010830ThinwallVASCUTEK LTD2015-10-22
05037881010847ThinwallVASCUTEK LTD2015-10-22
05037881010854ThinwallVASCUTEK LTD2015-10-22
05037881010861ThinwallVASCUTEK LTD2015-10-22
05037881010878ThinwallVASCUTEK LTD2015-10-22
05037881010885ThinwallVASCUTEK LTD2015-10-22

Legacy Summary

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FDA Review

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