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W. L. Gore & Associates, Inc.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories17
Latest FDA decision2026-08-03
TypeNumberDevice NameCodeDateActions
PMA P050006 Transcatheter septal occluderMLV2026-08-03 View
PMA P210032 SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTMIH2026-07-13 View
PMA P020004 SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTMIH2026-07-08 View
PMA P230023 Endovascular system for treatment of thoracoabdominal and pararenal aortic lesionsQZK2026-07-01 View
PMA P160021 Iliac covered stent, arterialPRL2026-06-16 View
PMA P130006 System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentPFV2026-05-26 View
PMA P040037 STENT, SUPERFICIAL FEMORAL ARTERYNIP2026-05-26 View
PMA P250017 Stent, vena cavaQTL2026-04-30 View
PMA P040043 SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTMIH2026-03-09 View
PMA P040027 SHUNT, PORTOSYSTEMIC, ENDOPROSTHESISMIR2025-10-27 View
510(k) K250410 GORE® Tri-Lobe Balloon CatheterDQY2025-06-02 View
510(k) K240083 GORE® PROPATEN® Vascular GraftDSY2024-03-01 View
510(k) K232312 GORE® PROPATEN® Vascular GraftDSY2024-01-09 View
510(k) K233551 GORE® ACUSEAL Vascular GraftDSY2023-12-19 View
510(k) K231505 GORE® ACUSEAL Vascular GraftDSY2023-06-23 View
PMA P160004 STENT, SUPERFICIAL FEMORAL ARTERYNIP2020-01-23 View
510(k) K191773 GORE BIO-A Tissue ReinforcementOWT2019-07-31 View
PMA P180010 Stent, carotidNIM2019-03-18 View
510(k) K181940 GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC2018-08-17 View
510(k) K173333 GORE ENFORM BiomaterialOXF2018-04-05 View

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Related Clinical Trials

NCT02380716ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic DissectionCOMPLETEDNCT03728985Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic AneurysmsACTIVE_NOT_RECRUITINGNCT03821129GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval StudyRECRUITINGNCT04100135GORE® CARDIOFORM Septal Occluder Migraine Clinical StudyTERMINATEDNCT04718168GORE® ENFORM Biomaterial Product StudyRECRUITINGNCT04907240Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global RegistryACTIVE_NOT_RECRUITINGNCT05409976The GORE® VIABAHN® FORTEGRA Venous Stent IVC StudyACTIVE_NOT_RECRUITINGNCT05489588The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral StudyACTIVE_NOT_RECRUITINGNCT05800743Evaluation of the GORE® Ascending Stent GraftENROLLING_BY_INVITATIONNCT05811364The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive DiseaseRECRUITING
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