Device, Vascular, For Promoting Embolization
FDA product code KRD · Class II (moderate risk) · 21 CFR 870.3300 · Cardiovascular
132510(k) clearances
1PMA approvals
17recalls
Implantimplanted device
Manufacturers
- MicroVention, Inc. 18
- Boston Scientific Corporation 16
- Cook, Inc. 13
- Biosphere Medical, S.A. 9
- Vascular Solutions, Inc. 5
- Reverse Medical Corporation 4
- Aga Medical Corp. 4
- Biocompatibles UK Limited 4
- Okami Medical, Inc. 4
- Celonova Biosciences, Inc. 4
- Target Therapeutics 3
- Artventive Medical Group, Inc. 3
- Nuvascular, Inc. 2
- Endoshape, Inc. 2
- Micro Therapeutics, Inc. 2
- Abk Biomedical, Inc. 2
- Suzhou Haowei Medical Technology Co., Ltd. 2
- Varian Medical Systems, Inc. 2
- Instylla, Inc. 2
- Shape Memory Medical 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
| K251383 | Prestige Coil System (Prestige Packing Line Extension)KRD · Special | Balt USA, LLC | 05/30/2025SE |
| K250971 | Embosphere MicrospheresKRD · Traditional | Biosphere Medical, S.A. | 05/16/2025SE |
| K250276 | Nitinol Enhanced Device (NED)KRD · Traditional | Embolization, Inc. | 05/15/2025SE |
| K250079 | Ruby XL SystemKRD · Traditional | Penumbra, Inc. | 03/14/2025SE |
| K242608 | Embozene Color-Advanced MicrospheresKRD · Traditional | Varian Medical Systems, Inc. | 01/17/2025SE |
| K240873 | TEMBO Embolic SystemKRD · Traditional | Instylla, Inc. | 12/16/2024SE |
| K242794 | ONCOZENE MicrospheresKRD · Special | Varian Medical Systems, Inc. | 10/16/2024SE |
| K242507 | OBSIDIO Conformable EmbolicKRD · Special | Boston Scientific | 10/03/2024SE |
| K232934 | SunsphereKRD · Traditional | Hangzhou Yangshun Medical Technology Co.,Ltd | 05/30/2024SE |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular…KRD · Traditional | Merit Medical Systems, Inc. | 05/02/2024SE |
| K234123 | Easi-Vue® embolic microspheres SystemKRD · Traditional | Abk Biomedical, Inc. | 02/13/2024SE |
| K231554 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 11/14/2023SE |
| K230706 | EMBOLD Soft Detachable Coil SystemKRD · Traditional | Boston Scientific Corporation | 06/27/2023SE |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD · Traditional | MicroVention, Inc. | 12/21/2022SE |
| K220567 | Easi-Vue embolic microspheres SystemKRD · Traditional | Abk Biomedical, Inc. | 09/07/2022SE |
| K213385 | GemKRD · Traditional | Obsidio, Inc. | 07/01/2022SE |
| K220383 | LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)KRD · Traditional | Okami Medical | 04/29/2022SE |
| K213398 | EMBOLD Fibered Detachable Coil SystemKRD · Traditional | Boston Scientific Corporation | 04/12/2022SE |
| K220699 | Prestige Coil SystemKRD · Special | Bait USA, LLC | 04/08/2022SE |
| K213200 | Solus Gold Embolization DeviceKRD · Traditional | Artio Medical, Inc. | 03/21/2022SE |
| K212057 | Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSKRD · Traditional | Artventive Medical Group, Inc. | 03/01/2022SE |
| K212817 | Merit Siege Vascular PlugKRD · Traditional | Merit Medical System, Inc. | 12/15/2021SE |
| K210562 | HRSpheres Narrow-Size Embolic MicrospheresKRD · Traditional | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 10/01/2021SE |
| K202850 | Concerto Versa, Detachable CoilKRD · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 02/09/2021SE |
| K203025 | LOBO Vascular Occlusion System (model LOBO-5)KRD · Special | Okami Medical | 11/05/2020SE |
| K191680 | AZUR Vascular PlugKRD · Traditional | MicroVention, Inc. | 03/20/2020SE |
| K200083 | EMBA Hourglass Peripheral Embolization Device (PED)KRD · Special | Embolic Acceleration, LLC | 02/14/2020SE |
| K191532 | The Caterpillar and Caterpillar Micro Arterial Embolization DevicesKRD · Traditional | C.R. Bard, Inc. | 02/04/2020SE |
| K192480 | Torpedo Gelatin FoamKRD · Traditional | Biosphere Medical, S.A. | 11/21/2019SE |
| K192083 | Okami Medical LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical | 10/30/2019SE |
| K183120 | EmboCube Embolization GelatinKRD · Traditional | Biosphere Medical, S.A. | 08/06/2019SE |
| K183578 | Torpedo Gelatin FoamKRD · Traditional | Biosphere Medical, S.A. | 06/18/2019SE |
| K182390 | IMPEDE-FX Embolization PlugKRD · Traditional | Shape Memory Medical | 05/23/2019SE |
| K182944 | Dr. Amplatz Micro PlugKRD · Traditional | Ka Medical, LLC | 04/17/2019SE |
| K181021 | EmboCube Embolization GelatinKRD · Traditional | Biosphere Medical, S.A. | 09/27/2018SE |
| K181300 | Embosphere MicrospheresKRD · Traditional | Biosphere Medical, S.A. | 07/16/2018SE |
| K181051 | IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…KRD · Traditional | Shape Memory Medical | 06/22/2018SE |
| K173891 | Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere…KRD · Special | Vascular Solutions, Inc. | 01/19/2018SE |
| K171946 | Gel-BeadKRD · Special | Vascular Solutions, Inc. | 10/25/2017SE |
| K172372 | QuadraSphere MicrospheresKRD · Special | Biosphere Medical, S.A. | 09/06/2017SE |
| K171845 | EMBA Hourglass Peripheral Embolization DeviceKRD · Traditional | Emba Medical Limited | 08/18/2017SE |
| K162524 | AZUR CX Detachable 18 Peripheral Coil SystemKRD · Traditional | MicroVention, Inc. | 03/03/2017SE |
| K162373 | LC Bead LUMIKRD · Traditional | Biocompatibles UK Limited | 12/16/2016SE |
| K160219 | Hilal Embolization MicroCoilsKRD · Traditional | Cook Incorporated | 08/03/2016SE |
| K153778 | Nester Embolization Coils, Tornado Embolization CoilsKRD · Traditional | Cook Incorporated | 05/19/2016SE |
| K150876 | Bead BlockKRD · Traditional | Biocompatibles UK , Ltd. | 03/07/2016SE |
| K150870 | HydroPearl Microspheres, HydroPearl MicrospheresKRD · Traditional | MicroVention, Inc. | 12/21/2015SE |
| K150964 | MReye Flipper Detachable Embolization Coil and Delivery SystemKRD · Traditional | Cook Incorporated | 12/18/2015SE |
| K150931 | MReye Embolization CoilsKRD · Traditional | Cook Incorporated | 12/18/2015SE |
| K152157 | LC Bead LUMIKRD · Traditional | Biocompatibles UK , Ltd. | 12/11/2015SE |
| K153102 | QuadraSphere MicrospheresKRD · Special | Biosphere Medical, S.A. | 11/23/2015SE |
| K151358 | AZUR CX Detachable 35 CoilsKRD · Traditional | MicroVention, Inc. | 09/25/2015SE |
| K150402 | Endoluminal Occlusion System-EOSKRD · Traditional | Artventive Medical Group, Inc. | 09/25/2015SE |
| K150958 | LifePearl MicroshperesKRD · Traditional | MicroVention, Inc. | 09/17/2015SE |
| K151187 | QuadraSphere MicrospheresKRD · Traditional | Biosphere Medical, S.A. | 07/27/2015SE |
| K151676 | Retracta Detachable Embolization CoilKRD · Special | Cook Incorporated | 07/22/2015SE |
| K150108 | Reverse Medical Micro Vascular Plug SystemKRD · Special | Reverse Medical Corporation | 04/22/2015SE |
| K133924 | Endoluminal Occlusion System (Eos)KRD · Abbreviated | Artventive Medical Group, Inc. | 12/03/2014SE |
| K140796 | Medusa Vascular Plug,KRD · Traditional | Endoshape, Inc. | 12/02/2014SE |
| K143038 | Gel-Block 10X embolization pledgetsKRD · Special | Vascular Solutions, Inc. | 11/20/2014SE |
| K141378 | Idc Interlocking Detachable CoilKRD · Traditional | Boston Scientific Corporation | 10/08/2014SE |
| K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…KRD · Traditional | Celonova Biosciences, Inc. | 08/07/2014SE |
| K141313 | Reverse Medical Micro Vascular Plug SystemKRD · Special | Reverse Medical Corporation | 06/18/2014SE |
| K133237 | Gel-Bead Embolization SpheresKRD · Traditional | Vascular Solutions, Inc. | 04/25/2014SE |
| K133626 | Azur Pure Peripheral Coil System, Pushable 35KRD · Special | MicroVention, Inc. | 12/20/2013SE |
| K133282 | Reverse Medical Micro Vascular Plug (MVP) SystemKRD · Special | Reverse Medical Corporation | 11/27/2013SE |
| K133208 | INTERLOCK-35 Fibered Idc Occlusion SystemKRD · Special | Boston Scientific Corp | 11/14/2013SE |
| K132083 | Azur Pure Peripheral Coil Systems, Pushable 35KRD · Traditional | MicroVention, Inc. | 10/28/2013SE |
| K123696 | Medusa Vascular PlugKRD · Traditional | Endoshape, Inc. | 10/25/2013SE |
| K132675 | Embozene MicrospheresKRD · Special | Celonova Biosciences, Inc. | 10/03/2013SE |
| K132578 | Interlock - 18 Fibered Idc Occlusion SystemKRD · Special | Boston Scientific Corp | 09/13/2013SE |
| K123803 | Reverse Medical Micro Vascular Plug (MVP) SystemKRD · Traditional | Reverse Medical Corporation | 07/02/2013SE |
| K130577 | Azur Pushable 18 & 35 SystemKRD · Special | MicroVention, Inc. | 06/17/2013SE |
| K130307 | Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…KRD · Special | Celonova Biosciences, Inc. | 03/04/2013SE |
| K123712 | Retracta Detachable Embolization CoilKRD · Special | Cook Incorporated | 01/03/2013SE |
| K123384 | Azur CX Detachable 18KRD · Special | MicroVention, Inc. | 11/28/2012SE |
| K122543 | Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…KRD · Traditional | MicroVention, Inc. | 11/28/2012SE |
| K122316 | Azur Detachable 35KRD · Special | MicroVention, Inc. | 08/29/2012SE |
| K113658 | Amplatzer Vascular Plug 4KRD · Traditional | Aga Medical Corp. | 06/12/2012SE |
| K113266 | Gel-Block Embolization PledgetsKRD · Traditional | Vascular Solutions, Inc. | 05/14/2012SE |
| K120816 | Inzone Detachment SystemKRD · Special | Stryker | 04/17/2012SE |
| K120630 | Azur Detachable 18KRD · Special | MicroVention, Inc. | 03/28/2012SE |
| K113651 | INTERLOCK-35 Fibered Idc Occlusion SystemKRD · Special | Boston Scientific Corporation | 01/11/2012SE |
| K112103 | INTERLOCK-35 Fibered Idc Occlusion SystemKRD · Special | Boston Scientific Corp | 08/12/2011SE |
| K111307 | Azur Detachable 35 Platinum Coil SystemKRD · Traditional | MicroVention, Inc. | 06/15/2011SE |
| K110295 | INTERLOCK-35 Fibered Idc Occlusion SystemKRD · Special | Boston Scientific Corp | 03/03/2011SE |
| K102912 | Interlock Fibered Idc Occlusion SystemKRD · Traditional | Boston Scientific | 03/03/2011SE |
| K102714 | Complex Helical 18, Multi-Loop 18, Figure 8-18, Straight 18 Fibered Platinum Coils…KRD · Traditional | Boston Scientific Corp | 02/11/2011SE |
| K102365 | Microplex Coil System- CosmosKRD · Traditional | MicroVention, Inc. | 11/18/2010SE |
| K091952 | Acta Vessel Occlusion System (Vos)KRD · Abbreviated | Nfocus Neuromedical, Inc. | 09/10/2010SE |
| K093813 | Occlusin 500 Artificial Embolization DeviceKRD · Traditional | Imbiotechnologies | 05/10/2010SE |
| K093002 | Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…KRD · Special | MicroVention, Inc. | 10/28/2009SE |
| K091882 | Azur Peripheral Hydrocoil Endovascular Embolization SystemKRD · Special | MicroVention, Inc. | 07/08/2009SE |
| K090624 | Cook Mreye Embolization CoilsKRD · Special | Cook, Inc. | 04/02/2009SE |
| K090046 | Concerto Detachable Coil SystemKRD · Special | Micro Therapeutics, Inc. | 02/27/2009SE |
| K083091 | LC Bead Microspheres, Bead Block Compressible MicrospheresKRD · Traditional | Biocompatibles UK Limited | 12/24/2008SE |
| K073417 | Embozene MicrospheresKRD · Traditional | Celonova Biosciences, Inc. | 12/15/2008SE |
| K081465 | Axium Detachable Coil SystemKRD · Traditional | Micro Therapeutics, Inc. | 08/19/2008SE |
| K073544 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…KRD · Traditional | Rj Medical, Inc. | 03/05/2008SE |
| K071939 | Hydrocoil Embolic Systems (Hes)KRD · Traditional | MicroVention, Inc. | 01/11/2008SE |
| K071699 | Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022KRD · Special | Aga Medical Corp. | 08/15/2007SE |
| K071125 | Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…KRD · Special | Aga Medical Corp. | 06/18/2007SE |
| K063619 | Flipper Detachable Embolization CoilsKRD · Special | Cook, Inc. | 12/20/2006SE |
| K052742 | Hepasphere MicrospheresKRD · Traditional | Biosphere Medical, Inc. | 11/07/2006SE |
| K061790 | Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesKRD · Traditional | Protein Polymer Technologies, Inc. | 09/19/2006SE |
| K060078 | Fibered Idc Occlusion SystemKRD · Special | Boston Scientific Corporation | 01/31/2006SE |
| K052834 | Mreye Embolization CoilKRD · Traditional | Cook, Inc. | 11/23/2005SE |
| K050470 | Concentric Embolic PearlsKRD · Traditional | Concentric Medical, Inc. | 05/06/2005SE |
| K043371 | Biomerix Vascular Occlusion Device and LoaderKRD · Traditional | Biomerix Corporation | 02/03/2005SE |
| K040342 | Interlocking Detachable Coil System (Idc)KRD · Traditional | Boston Scientific Corp | 04/13/2004SE |
| K034068 | Contour Se MicrospheresKRD · Traditional | Boston Scientific Corp | 03/26/2004SE |
| K031810 | Amplatzer Vascular PlugKRD · Traditional | Aga Medical Corp. | 09/09/2003SE |
| K993455 | Flipper Detachable Embolization CoilKRD · Traditional | Cook, Inc. | 01/11/2000SE |
| K992121 | Embolization Coil SystemKRD · Traditional | Cook, Inc. | 12/20/1999SE |
| K964112 | Berenstein CoilKRD · Traditional | Target Therapeutics | 02/26/1997SE |
| K955293 | Fibered Platinum Coil, .035 TypeKRD · Traditional | Target Therapeutics | 02/06/1996SE |
| K940189 | Coil Positioner SetKRD · Traditional | Cook, Inc. | 11/28/1994SE |
| K940982 | Arterial Embolization Device (KRD)KRD · Traditional | Cook, Inc. | 10/14/1994SE |
| K914786 | Target Therapeutics CoilsKRD · Traditional | Target Therapeutics | 04/20/1992SE |
| K892446 | Shiley Equipment Support Carts ESC-002 & ESCB-02KRD · Traditional | Shiley, Inc. | 07/14/1989SE |
| K882136 | Intersept* Oxygen Gas Line FilterKRD · Traditional | Medtronic Blood Systems, Inc. | 08/11/1988SE |
| K854273 | Silicone Oil 350 CnetistokeKRD · Traditional | Pacific Medical Industries | 11/22/1985SE |
PMA approvals
- P780011 Mini Balloon · Bd Becton Dickinson Vacutainer Systems Preanalytic · 05/15/1980
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2188-2025 Class II | LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50…Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which… | Microvention Inc. | 05/29/2025Open, Classified |
| Z-1989-2025 Class II | Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT…Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker… | Balt USA, LLC | 05/08/2025Open, Classified |
| Z-1762-2025 Class II | Tornado Embolization Microcoil, intended for embolization of selective vessel supply to…Cook Medical identified that devices from the affected device lots may contain the incorrectly sized… | Cook Incorporated | 04/17/2025Open, Classified |
| Z-1374-2024 Class I | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower… | Boston Scientific Corporation | 02/20/2024Open, Classified |
| Z-1042-2024 Class II | The Prestige Coil System is a product family of embolic coils with associated delivery…Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube.… | Balt USA, LLC | 01/03/2024Open, Classified |
| Z-0187-2024 Class II | AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324Peripheral coil system detachable has a potential of unsealed pouch packaging. | Microvention Inc. | 08/24/2023Open, Classified |
| Z-1242-2022 Class II | Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO…The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | Cook Incorporated | 05/05/2022Open, Classified |
| Z-1241-2022 Class II | Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER…The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | Cook Incorporated | 05/05/2022Open, Classified |
| Z-1240-2022 Class II | Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN…The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | Cook Incorporated | 05/05/2022Open, Classified |
| Z-1225-2020 Class II | Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019…The devices may be missing the implant coil. | Microvention, Inc. | 11/24/2019Terminated |
| Z-1224-2020 Class II | Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026…The devices may be missing the implant coil. | Microvention, Inc. | 11/24/2019Terminated |
| Z-1223-2020 Class II | Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization…The devices may be missing the implant coil. | Microvention, Inc. | 11/24/2019Terminated |
| Z-1222-2020 Class II | Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032…The devices may be missing the implant coil. | Microvention, Inc. | 11/24/2019Terminated |
| Z-1221-2020 Class II | Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026…The devices may be missing the implant coil. | Microvention, Inc. | 11/24/2019Terminated |
| Z-1220-2020 Class II | Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization…The devices may be missing the implant coil. | Microvention, Inc. | 11/24/2019Terminated |
| Z-0504-2014 Class II | Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is manufactured…Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All… | Stryker Neurovascular | 11/04/2013Terminated |
| Z-0874-2012 | Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is…ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as… | Micro Therapeutics Inc, dba ev3 Neurovascular | 03/01/2010Terminated |