Medical Device Manufacturer · US , Mchenry , IL

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

163 submissions · 148 cleared · Since 1980

163

Total

148

Cleared

0

Denied

FDA 510(k) cleared devices by W.L. Gore & Associates, Inc. Cardiovascular ✕

62 devices

1-12 of 62

Cleared Jun 02, 2025

GORE® Tri-Lobe Balloon Catheter

Cardiovascular · 109d

Cleared Mar 01, 2024

GORE® PROPATEN® Vascular Graft

Cardiovascular · 50d

Cleared Jan 09, 2024

GORE® PROPATEN® Vascular Graft

Cardiovascular · 160d

Cleared Dec 19, 2023

GORE® ACUSEAL Vascular Graft

Cardiovascular · 46d

Cleared Jun 23, 2023

GORE® ACUSEAL Vascular Graft

Cardiovascular · 30d

Cleared May 12, 2016

GORE DrySeal Flex Introducer Sheath

Cardiovascular · 101d

Cleared Apr 09, 2013

GORE ACUSEAL VASCULAR GRAFT

Cardiovascular · 70d

Cleared Dec 13, 2012

GORE FLOW REVERSAL SYSTEM MODEL GFRS073

Cardiovascular · 65d

Cleared Nov 20, 2012

GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING

Cardiovascular · 210d

Cleared Apr 20, 2012

GORE DRYSEAL SHEATH

Cardiovascular · 67d

Cleared May 23, 2011

GORE EMBOLIC FILTER

Cardiovascular · 175d

Cleared Mar 22, 2010

GORE DRYSEAL SHEATH

Cardiovascular · 102d

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