FDA.report

510(k) K082356

Device
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
Applicant
W. L. GORE & ASSOCIATES, INC.
510(k) number
K082356
Product code
DYB  
Decision
Substantially Equivalent (SESE)
Decision date
2008-08-28
Date received
2008-08-18
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
ALICIA HEMPHILL
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

Legacy Summary

summary

FDA Review

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