FDA.report

510(k) K070770

Device
GORE BALLOON SHEATH
Applicant
W. L. GORE & ASSOCIATES, INC.
510(k) number
K070770
Product code
MJN  
Decision
Substantially Equivalent (SESE)
Decision date
2007-06-29
Date received
2007-03-20
Regulation
870.4450
Classification name
Catheter, Intravascular Occluding, Temporary
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
ALAN CURTIS
Address
2647 Lin Gate Ct. Pleasanton CA US 94566 94566

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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