Medical Device Manufacturer · US , Phoenix , AZ

W. L. Gore and Associates, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2018

Official Website

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - W. L. Gore and Associates, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Oct 05, 2018

GORE Tri-Lumen Catheter

Cardiovascular · 179d

Cleared Jan 31, 2018

GORE Molding and Occlusion Balloon Catheter

Cardiovascular · 159d