Medical Device Manufacturer · US , Phoenix , AZ

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

3 submissions · 3 cleared · Since 2018
3
Total
3
Cleared
0
Denied

W. L. Gore and Associates, Inc. is a medical device manufacturer with a manufacturing facility in Phoenix, US. The company specializes in cardiovascular and surgical devices.

The company has received 3 FDA 510(k) clearances from 3 total submissions between 2018 and 2022. Its cleared devices focus primarily on cardiovascular applications, including catheter systems and biomaterials for general and plastic surgery. This regulatory record reflects the company's historical activity in the medical device sector.

Notable cleared devices include catheter systems designed for cardiovascular interventions and advanced biomaterials for surgical applications. The company's most recent FDA 510(k) clearance was in 2022, with no submissions recorded since then.

Explore the complete list of device names, product codes, and clearance dates in the database records below.

FDA 510(k) Regulatory Record - W. L. Gore and Associates, Inc.
3 devices
1-3 of 3
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