FDA.report

510(k) K964665

Device
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
Applicant
CARBOMEDICS, INC.
510(k) number
K964665
Product code
DSY  
Decision
Se Subject To Tracking Reg (ST)
Decision date
1997-02-19
Date received
1996-11-21
Regulation
870.3450
Classification name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
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 not indicated by FDA · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
05037881020594Gelweave™VASCUTEK LTD2015-10-19
05037881020587Gelweave™VASCUTEK LTD2015-10-19
05037881013541Gelweave™VASCUTEK LTD2015-10-19

Legacy Summary

summary

FDA Review

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