FDA.report

510(k) K081799

Device
GORE TRI-LOBE BALLOON CATHETER
Applicant
W. L. GORE & ASSOCIATES, INC.
510(k) number
K081799
Product code
DQY  
Decision
Substantially Equivalent (SESE)
Decision date
2008-10-03
Date received
2008-06-25
Regulation
870.1250
Classification name
Catheter, Percutaneous
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
KANU H VADODARIA
Address
3450 W. Kiltie Ln. Flagstaff AZ US 86001 86001

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
H373BCM163434GORE Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.2017-02-13
H373BCL264536GORE Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc.2017-02-13

Legacy Summary

summary

FDA Review

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