Chrysalis Intelligence · Sponsors · W. L. Gore & Associates, Inc.

W. L. Gore & Associates, Inc.

Flagstaff, AZ, US · 5 510(k) clearances · 278 PMAs · 25 recalls

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Total clearances
5
2023-06-23 → 2025-06-02
Last 12 months
0
Product codes
2
Most recent
2025-06-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Class II Cardiovascular 4 2024-03-01
DQY — — — 1 2025-06-02
Class III

PMA approvals (278)

Total PMA records
278
Originals + supplements
Distinct product codes
9
First decision
2020-01-23
Most recent
2026-08-03
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-03 P050006-S119 GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder Special (Immediate Track) MLV — —
2026-07-13 P210032-S026 GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-07-08 P020004-S207 GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-07-01 P230023-S012 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Special (Immediate Track) QZK — —
2026-06-23 P020004-S208 GORE® EXCLUDER® AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-06-16 P160021-S052 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2026-05-26 P130006-S111 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2026-05-26 P040037-S172 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-05-14 P020004-S205 GORE® EXCLUDER® AAA Endoprosthesis Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-05-08 P050006-S118 GORE® CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2026-04-30 P250017-S003 GORE® VIABAHN® FORTEGRA Venous Stent 30-Day Notice QTL — —
2026-04-28 P020004-S206 GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-04-09 P230023-S011 GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) 30-Day Notice QZK — —
2026-04-07 P250017-S001 GORE® VIABAHN® FORTEGRA Venous Stent Normal 180 Day Track No User Fee QTL — —
2026-03-09 P210032-S025 GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-03-09 P040043-S149 GORE® TAG® Conformable Thoracic Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-03-09 P040043-S148 GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-03-06 P250017-S002 GORE® VIABAHN® FORTEGRA Venous Stent 30-Day Notice QTL — —
2026-02-20 P050006-S117 GORE® CARDIOFORM ASD Occluder; GORE® CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2026-02-05 P160021-S050 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2026-01-15 P230023-S010 GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Normal 180 Day Track No User Fee QZK — —
2025-12-19 P250017 GORE® VIABAHN® FORTEGRA Venous Stent Original QTL — —
2025-12-19 P050006-S116 GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2025-11-24 P160021-S048 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Normal 180 Day Track PRL Iliac Covered Stent, Arterial Unknown
2025-10-27 P040027-S099 GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion Normal 180 Day Track MIR Shunt, Portosystemic, Endoprosthesis Unknown
2025-10-17 P210032-S024 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-10-17 P160021-S049 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2025-10-17 P130006-S110 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2025-10-17 P040037-S171 GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-10-15 P040043-S147 GORE® TAG® Conformable Thoracic Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-10-09 P020004-S204 GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-10-02 P040043-S146 GORE® TAG® Conformable Thoracic Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-09-09 P230023-S009 GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis 30-Day Notice QZK — —
2025-09-09 P210032-S023 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-09-09 P040043-S145 Conformable GORE® TAG® Thoracic Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-09-09 P020004-S203 GORE® EXCLUDER® Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-08-29 P040043-S144 GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS) 00733132646890; 00733132646906; 007331326 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-08-25 P210032-S022 TAG® Thoracic Branch Endoprosthesis (P210032) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-08-21 P210032-S019 GORE TAG Thoracic Branch Endoprosthesis (TBE Device) Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-08-20 P020004-S202 GORE® EXCLUDER® AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-08-07 P020004-S201 EXCLUDER BIFURCATED ENDOPROSTHESIS 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-07-16 P040043-S143 GORE® TAG® Conformable Thoracic Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-06-13 P130006-S109 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2025-06-13 P040037-S170 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-06-11 P210032-S020 GORE TAG Thoracic Branch Endoprosthesis (TBE Device) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-06-11 P020004-S199 GORE® EXCLUDER® AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-06-05 P230023-S008 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis 30-Day Notice QZK — —
2025-06-05 P210032-S021 GORE TAG Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-06-05 P130006-S108 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2025-06-05 P040043-S142 Conformable GORE® TAG® Thoracic Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-06-05 P040037-S169 GORE® VIABAHN® Endoprosthesis 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-06-05 P020004-S200 GORE® EXCLUDER® AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-05-20 P230023-S006 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) Normal 180 Day Track QZK — —
2025-05-20 P160021-S047 Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (RP VBX Device) Normal 180 Day Track PRL Iliac Covered Stent, Arterial Unknown
2025-04-11 P210032-S015 GORE TAG Thoracic Branch Endoprosthesis (TBE Device) Panel Track SDZ — —
2025-04-09 P040027-S098 GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion Real-Time Process MIR Shunt, Portosystemic, Endoprosthesis Unknown
2025-03-28 P130006-S107 GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2025-03-28 P040037-S168 GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-03-14 P050006-S115 GORE CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2025-03-03 P020004-S198 GORE® EXCLUDER AAA Endoprosthesis; Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-02-21 P130006-S106 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2025-02-21 P040037-S167 GORE® VIABAHN® Endoprosthesis 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-02-10 P020004-S197 EXCLUDER BIFURCATED ENDOPROSTHESIS 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-01-17 P050006-S111 GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder Normal 180 Day Track MLV — —
2025-01-03 P230023-S007 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis 30-Day Notice QZK — —
2024-12-23 P230023-S004 GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Real-Time Process QZK — —
2024-12-16 P040043-S140 GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS) Normal 180 Day Track MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-12-13 P050006-S114 GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2024-11-18 P230023-S005 GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Normal 180 Day Track No User Fee QZK — —
2024-11-18 P040043-S137 Conformable Gore® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-11-14 P210032-S018 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-10-17 P050006-S113 GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2024-10-11 P210032-S017 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-10-11 P040043-S141 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-10-09 P050006-S112 GORE CARDIOFORM ASD Occluder Special (Immediate Track) MLV — —
2024-10-03 P210032-S016 GORE TAG Thoracic Branch Endoprosthesis (TBE) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-09-12 P040027-S097 GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2024-09-10 P130006-S105 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2024-09-10 P040037-S166 GORE® VIABAHN® Endoprosthesis 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-08-16 P210032-S014 GORE® TAG® Thoracic Branch Endoprosthesis Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-08-16 P040043-S139 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-08-13 P230023-S003 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Normal 180 Day Track No User Fee QZK — —
2024-07-03 P040043-S138 Conformable GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-06-27 P210032-S013 GORE TAG Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-06-27 P160021-S045 GORE VIABAHN VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2024-06-27 P130006-S104 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2024-06-27 P040037-S165 GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-06-21 P230023-S002 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Normal 180 Day Track No User Fee QZK — —
2024-06-18 P160021-S046 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Special (Immediate Track) PRL Iliac Covered Stent, Arterial Unknown
2024-06-04 P160021-S044 GORE VIABAHN VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2024-05-15 P040043-S136 GORE TAG Conformable Thoracic Stent Graft with Active Control System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-04-29 P050006-S109 GORE® CARDIOFORM ASD Occluder, GORE® CARDIOFORM Septal Occluder Real-Time Process MLV — —
2024-04-18 P050006-S110 GORE® CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2024-04-03 P020004-S196 GORE® EXCLUDER® AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-04-02 P160021-S043 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Normal 180 Day Track No User Fee PRL Iliac Covered Stent, Arterial Unknown
2024-03-27 P160021-S042 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Special (Immediate Track) PRL Iliac Covered Stent, Arterial Unknown
2024-03-22 P230023-S001 GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Normal 180 Day Track No User Fee QZK — —
2024-03-20 P050006-S107 GORE® CARDIOFORM ASD Occluder Normal 180 Day Track No User Fee MLV — —
2024-02-28 P130006-S103 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2024-02-28 P040037-S164 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-02-07 P040027-S095 Gore Viatorr TIPS Special (Immediate Track) MIR Shunt, Portosystemic, Endoprosthesis Unknown
2024-02-06 P040027-S096 GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2024-01-12 P230023 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Original QZK — —
2024-01-03 P130006-S102 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Real-Time Process PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2024-01-03 P040037-S163 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Real-Time Process NIP Stent, Superficial Femoral Artery Unknown
2023-12-08 P040027-S094 GORE® VIATORR® TIPS Endoprosthesis 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2023-11-17 P210032-S012 GORE TAG Thoracic Branch Endoprosthesis (TBE) Side Branch 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-11-15 P160021-S039 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Normal 180 Day Track PRL Iliac Covered Stent, Arterial Unknown
2023-10-30 P050006-S108 GORE® CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2023-09-11 P050006-S106 GORE® CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2023-09-07 P130006-S101 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2023-09-07 P040037-S162 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-08-30 P210032-S011 GORE TAG Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-08-15 P020004-S195 GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-07-21 P130006-S098 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2023-07-21 P040037-S159 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-07-18 P130006-S100 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2023-07-18 P040037-S161 GORE® VIABAHN® Endoprosthesis 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-07-13 P160021-S040 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-07-05 P210032-S010 GORE® TAG® Thoracic Branch Endoprosthesis (Side Branch Component only) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-07-05 P160021-S041 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-07-05 P130006-S099 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2023-07-05 P040037-S160 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-06-20 P210032-S009 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-06-20 P040043-S135 Conformable GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-05-02 P210032-S007 GORE TAG Thoracic Branch Endoprosthesis (TBE Device) Normal 180 Day Track MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-04-24 P160021-S038 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-03-16 P210032-S008 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-03-16 P160021-S037 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2023-03-16 P130006-S097 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2023-03-16 P130006-S096 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2023-03-16 P040037-S158 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-03-16 P040037-S157 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-03-08 P040043-S134 GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-02-13 P210032-S006 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-02-13 P130006-S095 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2023-02-13 P040043-S133 GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-02-13 P040037-S156 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-02-13 P040027-S093 GORE® VIATORR® TIPS Endoprosthesis 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2023-02-13 P020004-S194 GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-01-12 P040043-S132 GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-12-21 P210032-S005 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-12-21 P160021-S036 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2022-12-21 P130006-S094 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2022-12-21 P050006-S105 GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2022-12-21 P040037-S155 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-12-15 P050006-S104 GORE® CARDIOFORM ASD Occluder Special (Immediate Track) MLV — —
2022-11-18 P020004-S193 GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-10-14 P050006-S101 GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder Real-Time Process MLV — —
2022-10-05 P210032-S004 GORE® TAG® Thoracic Branch Endoprosthesis (TBE) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-10-05 P040043-S131 Conformable GORE® TAG® Conformable Thoracic Stent Graft w/ ACTIVE CONTROL System (CMDS) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-10-05 P020004-S192 GORE® EXCLUDER® AAA Endoprosthesis (AAA) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-09-23 P050006-S102 GORE® CARDIOFORM Septal Occluder (GSO) 30-Day Notice MLV — —
2022-09-13 P020004-S191 GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-09-01 P130006-S093 GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2022-09-01 P040037-S154 GORE VIABAHN Endoprosthesis 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-08-31 P020004-S190 GORE(R) EXCLUDER(R) AAA Endoprosthesis, GORE(R) EXCLUDER(R) Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-08-24 P040027-S092 GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2022-08-05 P210032-S003 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-07-28 P020004-S189 GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-07-21 P210032-S002 GORE® TAG® Thoracic Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-07-08 P210032-S001 GORE® TAG® Thoracic Branch Endoprosthesis Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-07-07 P040027-S091 GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2022-07-06 P050006-S100 GORE CARDIOFORM Septal Occluder Normal 180 Day Track No User Fee MLV — —
2022-07-05 P160021-S035 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2022-05-26 P130006-S091 GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface Normal 180 Day Track No User Fee PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2022-05-26 P040037-S152 GORE VIABAHN Endoprosthesis Normal 180 Day Track No User Fee NIP Stent, Superficial Femoral Artery Unknown
2022-05-13 P210032 GORE TAG Thoracic Branch Endoprosthesis (TBE Device) Original MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-05-09 P050006-S099 GORE CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2022-03-18 P160021-S034 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2022-03-18 P130006-S090 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2022-03-18 P040037-S151 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-03-03 P130006-S092 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2022-03-03 P040037-S153 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-02-22 P160021-S033 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2022-02-22 P130006-S089 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2022-02-22 P050006-S098 GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2022-02-22 P040043-S130 GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-02-22 P040037-S150 GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-02-22 P040027-S090 GORE® VIATORR® TIPS Endoprosthesis 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2022-02-22 P020004-S187 GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-02-11 P020004-S188 GORE EXCLUDER AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-01-28 P130006-S087 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Real-Time Process PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2022-01-28 P040037-S148 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Real-Time Process NIP Stent, Superficial Femoral Artery Unknown
2022-01-28 P020004-S185 GORE® EXCLUDER® AAA Endoprosthesis Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-01-27 P050006-S097 GORE CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2021-12-21 P050006-S093 GORE CARDIOFORM Septal Occluder Normal 180 Day Track No User Fee MLV — —
2021-12-16 P020004-S186 GORE®1 EXCLUDER® AAA Endoprosthesis (AAA), GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-12-03 P130006-S088 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-12-03 P040037-S149 GORE® VIABAHN® Endoprosthesis 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-11-29 P050006-S096 GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2021-11-16 P050006-S095 GORE® CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2021-11-12 P130006-S086 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-11-12 P040037-S147 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-11-12 P040027-S089 GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2021-10-22 P020004-S184 GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-09-24 P130006-S085 GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-09-24 P040037-S146 GORE® VIABAHN® Endoprosthesis 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-09-24 P040027-S088 GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2021-09-24 P020004-S182 GORE EXCLUDER Iliac Branch Endoprosthesis, GORE EXCLUDER Conformable AAA Endoprothesis Normal 180 Day Track MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-09-01 P160021-S032 GORE VIABAHN VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2021-08-13 P130006-S084 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-08-13 P050006-S094 GORE CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2021-08-13 P040037-S145 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-08-13 P020004-S183 GORE EXCLUDER AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-08-02 P160021-S029 GORE VIABAHN VBX Balloon Expandable Endoprosthesis Normal 180 Day Track No User Fee PRL Iliac Covered Stent, Arterial Unknown
2021-08-02 P130006-S082 GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family Normal 180 Day Track No User Fee PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-08-02 P050006-S091 GORE CARDIOFORM Septal Occluder and GORE CARDIOFORM ASD Occluder Normal 180 Day Track No User Fee MLV — —
2021-08-02 P040043-S123 GORE TAG Thoracic Endoprosthesis product family Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-08-02 P040037-S143 GORE VIABAHN Endoprosthesis product family and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family Normal 180 Day Track No User Fee NIP Stent, Superficial Femoral Artery Unknown
2021-08-02 P040027-S086 GORE VIATORR TIPS Endoprosthesis product family Normal 180 Day Track No User Fee MIR Shunt, Portosystemic, Endoprosthesis Unknown
2021-08-02 P020004-S179 GORE EXCLUDER AAA Endoprosthesis product family Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-06-16 P040043-S129 GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-05-04 P040043-S128 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-05-04 P040043-S127 Conformable GORE TAG Thoracic Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-04-15 P130006-S083 GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-04-15 P050006-S092 GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2021-04-15 P040043-S126 GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-04-15 P040037-S144 GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-04-15 P040027-S087 GORE VIATORR TIPS Endoprosthesis 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2021-04-15 P020004-S181 GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-04-08 P040043-S125 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-03-31 P160021-S031 GORE VIABAHN VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2021-03-25 P160021-S030 GORE VIABAHN VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2021-03-25 P040043-S124 GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-03-25 P020004-S180 GORE EXCLUDER Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-03-04 P040027-S085 GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2021-03-04 P040027-S084 GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2021-01-26 P050006-S089 GORE Cardioform Septal Occluder and GORE Cardioform ASD Occluder 30-Day Notice MLV — —
2021-01-22 P160021-S027 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2021-01-22 P130006-S080 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2021-01-22 P050006-S088 GORE® CARDIOFORM Septa! Occluder and GORE® CARDIOFORM ASD Occluder 30-Day Notice MLV — —
2021-01-22 P040043-S121 GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-01-22 P040037-S141 GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-01-22 P040027-S082 GORE® VIATORR® TIPS Endoprosthesis 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2021-01-22 P020004-S177 GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-12-18 P050006-S086 GORE CARDIOFORM ASD Occluder Normal 180 Day Track No User Fee MLV — —
2020-12-04 P050006-S087 GORE CARDIOFORM Septal Occluder 30-Day Notice MLV — —
2020-12-04 P040027-S081 GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2020-11-25 P040027-S080 GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2020-10-23 P050006-S085 GORE CARDIOFORM Septal Occluder Normal 180 Day Track No User Fee MLV — —
2020-10-15 P040043-S120 Gore TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-10-13 P130006-S079 GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-10-13 P040037-S140 GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-10-05 P040043-S118 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-09-16 P020004-S176 GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-09-02 P040043-S119 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-08-06 P050006-S084 GORE CARDIOFORM ASD Occluder Real-Time Process MLV — —
2020-08-05 P040043-S117 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-07-31 P040043-S116 GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-07-31 P020004-S175 GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-07-15 P130006-S078 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-07-15 P040037-S139 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-07-15 P040027-S079 GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2020-07-09 P040043-S115 Gore TAG Thoracic Stent Graft with ACTIVE CONTROL System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-07-02 P050006-S083 GORE CARDIOFORM ASD Occluder Special (Immediate Track) MLV — —
2020-06-03 P130006-S076 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-06-03 P040037-S137 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-05-22 P130006-S077 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-05-22 P040037-S138 GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-04-10 P050006-S082 GORE CARDIOFORM Occluder product family 30-Day Notice MLV — —
2020-04-10 P040043-S114 GORE TAG Thoracic Endoprosthesis product family 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-04-10 P020004-S174 GORE EXCLUDER AAA Endoprosthesis product family 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-04-08 P160021-S026 GORE VIABAHN VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2020-03-04 P130006-S075 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-03-04 P040037-S136 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-03-04 P040027-S078 GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2020-03-04 P020004-S173 Gore Excluder AAA Endoprosthesis 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-02-28 P160021-S024 GORE VIABAHN VBX Balloon Expandable Endoprosthesis Normal 180 Day Track No User Fee PRL Iliac Covered Stent, Arterial Unknown
2020-02-28 P130006-S073 GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family Normal 180 Day Track No User Fee PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-02-28 P040037-S134 GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family Normal 180 Day Track No User Fee NIP Stent, Superficial Femoral Artery Unknown
2020-02-28 P040027-S074 GORE VIATORR TIPSEndoprosthesis product family Normal 180 Day Track No User Fee MIR Shunt, Portosystemic, Endoprosthesis Unknown
2020-02-05 P020004-S166 GORE EXCLUDER AAA Endoprosthesis Normal 180 Day Track MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-01-29 P040027-S077 Gore Viatorr Tips Endoprosthesis and Gore Viatorr Tips Endoprosthesis with Controlled Expansion 30-Day Notice MIR Shunt, Portosystemic, Endoprosthesis Unknown
2020-01-23 P160021-S025 GORE VIABAHN VBX Balloon Expandable Endoprosthesis 30-Day Notice PRL Iliac Covered Stent, Arterial Unknown
2020-01-23 P160004-S029 GORE TIGRIS Vascular Stent 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-01-23 P130006-S074 GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown
2020-01-23 P040037-S135 GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
Safety

Recalls (25)

Class I (serious)
0
Risk of injury / death
Total recalls
25
Currently ongoing
22
Most recent
2025-08-26
DateSeverityStatusRecall # ProductCodeReason
2025-08-26 Class II Ongoing Z-0036-2026 GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, EC… — Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reinterventi…
2024-07-03 Class II Ongoing Z-2513-2024 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25; — Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
2024-07-01 Class II Ongoing Z-2946-2024 Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BX… — Due to packaging defects, sterility assurance and heparin activity may be compromised.
2024-07-01 Class II Ongoing Z-2945-2024 Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BX… — Due to packaging defects, sterility assurance and heparin activity may be compromised.
2024-01-19 Class II Ongoing Z-1179-2024 GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with ho… — Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending…
2022-12-14 Class II Ongoing Z-1048-2023 GORE CARDIOFORM Septal Occluder, REF: GSX0030A — Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure…
2022-09-21 Class II Ongoing Z-0136-2023 GORE CARDIOFORM ASD Occluder. cardiovascular implant. — Due to manufacturing records (Release Test Results) indicating "Failed".
2021-09-07 Class II Ongoing Z-0077-2022 Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLB… — Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
2021-09-02 Class II Ongoing Z-0172-2022 REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery P… — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-09-02 Class II Ongoing Z-0171-2022 REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery … — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-09-02 Class II Ongoing Z-0170-2022 REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery … — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-09-02 Class II Ongoing Z-0169-2022 REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery P… — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-09-02 Class II Ongoing Z-0168-2022 REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery P… — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-09-02 Class II Ongoing Z-0167-2022 REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery P… — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-09-02 Class II Ongoing Z-0166-2022 REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery P… — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-09-02 Class II Ongoing Z-0165-2022 REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery P… — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-09-02 Class II Ongoing Z-0164-2022 REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery P… — Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
2021-07-12 Class II Ongoing Z-2340-2021 Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compat… — Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or …
2021-05-12 Class II Ongoing Z-2293-2021 Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the … — Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectl…
2021-05-12 Class II Ongoing Z-2292-2021 Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the … — Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectl…
2021-04-05 Class II Terminated Z-1593-2021 GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH10… — The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
2020-09-09 Class II Ongoing Z-0291-2021 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System — When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the de…
2020-09-09 Class II Ongoing Z-0290-2021 GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System — Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
2020-01-06 Class II Terminated Z-0996-2020 GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE) — Firm has received reports of leading end catheter component separations.
2020-01-06 Class II Terminated Z-0995-2020 GORE¿ EXCLUDER¿ AAA Endoprosthesis — Firm has received reports of leading end catheter component separations.
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-06-02 K250410 GORE® Tri-Lobe Balloon Catheter DQY — —
2024-03-01 K240083 GORE® PROPATEN® Vascular Graft DSY Class II Cardiovascular
2024-01-09 K232312 GORE® PROPATEN® Vascular Graft DSY Class II Cardiovascular
2023-12-19 K233551 GORE® ACUSEAL Vascular Graft DSY Class II Cardiovascular
2023-06-23 K231505 GORE® ACUSEAL Vascular Graft DSY Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence