FDA.reportPublic FDA data

Non-neurovascular embolization plug, metallic

Definition
A non-bioabsorbable, metal device intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is in the form of an expandable metal scaffold, which once expanded is intended to induce thrombosis and create a blockage; it is typically supplied with instruments dedicated to implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.
GUDID devices
38
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850008222092LOBOOKAMI MEDICAL, INC.LOBO-3-LP2026-05-19
00850072397481HARBORNuvascular, Inc.04-OCCLUDE-0202025-07-30
00850072397498HARBORNuvascular, Inc.04-OCCLUDE-0252025-07-30
00850072397504HARBORNuvascular, Inc.04-OCCLUDE-0302025-07-30
00850072397511HARBORNuvascular, Inc.04-OCCLUDE-0352025-07-30
00850072397528HARBORNuvascular, Inc.04-OCCLUDE-0402025-07-30
00850072397535HARBORNuvascular, Inc.04-OCCLUDE-0452025-07-30
00850072397542HARBORNuvascular, Inc.04-OCCLUDE-0502025-07-30
00850072397559HARBORNuvascular, Inc.04-OCCLUDE-0552025-07-30
00850072397566HARBORNuvascular, Inc.04-OCCLUDE-0602025-07-30
00850072397573HARBORNuvascular, Inc.04-OCCLUDE-0652025-07-30
00850072397580HARBORNuvascular, Inc.04-OCCLUDE-0702025-07-30
00850072397597HARBORNuvascular, Inc.04-OCCLUDE-0802025-07-30
00850072397603HARBORNuvascular, Inc.04-OCCLUDE-0902025-07-30
00850072397610HARBORNuvascular, Inc.04-OCCLUDE-1002025-07-30
00850072397627HARBORNuvascular, Inc.04-OCCLUDE-1102025-07-30
00850072397634HARBORNuvascular, Inc.04-OCCLUDE-1202025-07-30
00842429101612AZUR VACULAR PLUGMicrovention, Inc.45-1805002025-04-30
00842429101629AZUR VACULAR PLUGMicrovention, Inc.45-1808002025-04-30
00842429101636AZUR VACULAR PLUGMicrovention, Inc.45-1810002025-04-30
00884450815908SIEGE™Merit Medical Systems, Inc.Initial Release2025-02-15
00884450815915SIEGE™Merit Medical Systems, Inc.Initial Release2025-02-15
00884450815922SIEGE™Merit Medical Systems, Inc.Initial Release2025-02-15
B617PG1111ArtVentive Endoluminal Occlusion System (EOS) Artventive Medical Group, Inc.11mm Implant2024-02-05
B617PG151ArtVentive Endoluminal Occlusion System (EOS) Artventive Medical Group, Inc.5mm Implant2024-02-05
B617PG181ArtVentive Endoluminal Occlusion System (EOS) Artventive Medical Group, Inc.8mm Implant2024-02-05
B617PSG161ArtVentive Endoluminal Occlusion System (EOS) Artventive Medical Group, Inc.6Fr Guide Catheter2024-02-05
B617PSG1751ArtVentive Endoluminal Occlusion System (EOS) Artventive Medical Group, Inc.7.5Fr Guide Catheter2024-02-05
00850034171005Solus Gold™ Embolization DeviceArtio Medical, IncSG302022-08-31
00850034171012Solus Gold™ Embolization Device Artio Medical, IncSG352022-08-31
00850034171029Solus Gold™ Embolization DeviceArtio Medical, IncSG402022-08-31
00850034171036Solus Gold™ Embolization DeviceArtio Medical, IncSG452022-08-31
00850034171043Solus Gold™ Embolization DeviceArtio Medical, IncSG502022-08-31
00850034171050Solus Gold™ Embolization DeviceArtio Medical, IncSG552022-08-31
00850034171067Solus Gold™ Embolization DeviceArtio Medical, IncSG602022-08-31
00850008222030LOBOOKAMI MEDICAL, INC.LOBO-72022-06-28
00850008222061LOBOOKAMI MEDICAL, INC.LOBO-92022-06-28
00850008222054LOBOOKAMI MEDICAL, INC.LOBO-52021-02-09