FDA.report

510(k) K963611

Device
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
Applicant
VASCUTEK LTD.
510(k) number
K963611
Product code
DXZ  
Decision
Substantially Equivalent (SESE)
Decision date
1996-11-21
Date received
1996-09-10
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
TEENA M AUGOSTINO
Address
1300 E. Anderson Ln. Austin TX US 78752 78752

FDA Registration Numbers

Source Documents

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

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05037881010816ThinwallVASCUTEK LTD2015-10-22
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05037881010830ThinwallVASCUTEK LTD2015-10-22
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05037881010854ThinwallVASCUTEK LTD2015-10-22
05037881010861ThinwallVASCUTEK LTD2015-10-22
05037881010878ThinwallVASCUTEK LTD2015-10-22
05037881010885ThinwallVASCUTEK LTD2015-10-22
05037881010892ThinwallVASCUTEK LTD2015-10-22

Legacy Summary

summary

FDA Review

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