Device, Neurovascular Embolization
FDA product code HCG · Class II (moderate risk) · 21 CFR 882.5950 · Neurology
187510(k) clearances
0PMA approvals
68recalls
Implantimplanted device
Manufacturers
- MicroVention, Inc. 32
- Cordis Neurovascular, Inc. 13
- Stryker Neurovascular 11
- Micrus Endovascular Corporation 11
- Micro Therapeutics, Inc. 11
- Boston Scientific, Target 11
- Boston Scientific Corporation 11
- Penumbra, Inc. 10
- Target Therapeutics 9
- Interventional Therapeutics Corp. 7
- Codman & Shurtleff, Inc. 7
- Blockade Medical 6
- Micrus Corp. 5
- Balt USA, LLC 5
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 4
- MicroPort NeuroTech (Shanghai) Co., Ltd. 4
- Surgica Corp. 3
- Biosphere Medical, Inc. 3
- Biocompatibles UK Limited 3
- Medos International SARL 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special | Cerenovus, Inc. | 08/14/2026SE |
| K261772 | Target Xtra Detachable CoilHCG · Special | Stryker Neurovscular | 06/24/2026SE |
| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 05/20/2026SE |
| K254221 | Optima Coil System (OptiOne Coil System)HCG · Special | Balt USA, LLC | 01/27/2026SE |
| K252694 | Target Detachable CoilHCG · Traditional | Stryker Neurovascular | 12/11/2025SE |
| K251832 | InZone IST Detachment System; IZDS Connecting CableHCG · Special | Stryker Neurovascular | 10/17/2025SE |
| K252700 | Optima Coil System (Optima Packing Coil System)HCG · Special | Balt USA, LLC | 09/26/2025SE |
| K242154 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 09/30/2024SE |
| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | Balt USA, LLC | 09/27/2024SE |
| K242243 | Target Detachable CoilsHCG · Special | Stryker Neurovscular | 08/29/2024SE |
| K232955 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 01/10/2024SE |
| K233420 | Axium Detachable Coil; Axium Prime Detachable CoilHCG · Special | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 11/07/2023SE |
| K230284 | Penumbra LP Coil SystemHCG · Traditional | Penumbra, Inc. | 10/25/2023SE |
| K222533 | Target Tetra Detachable CoilsHCG · Traditional | Stryker Neurovascular | 12/14/2022SE |
| K223386 | Optima Coil SystemHCG · Special | Balt USA, LLC | 12/06/2022SE |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…HCG · Traditional | Medos International SARL | 07/14/2022SE |
| K212455 | InZone Detachment SystemHCG · Traditional | Stryker Neurovascular | 11/16/2021SE |
| K203625 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Traditional | MicroPort NeuroTech (Shanghai) Co., Ltd. | 09/01/2021SE |
| K203432 | Axium Detachable Coil; Axium Prime Detachable CoilHCG · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 07/07/2021SE |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…HCG · Special | Medos International SARL | 05/28/2021SE |
| K210638 | i-ED COIL SystemHCG · Special | Kaneka Medical America, LLC | 03/26/2021SE |
| K192068 | i-ED COILHCG · Traditional | Kaneka Pharma America, LLC | 04/25/2020SE |
| K200030 | Optima Coil SystemHCG · Special | Balt USA, LLC | 02/01/2020SE |
| K192955 | Penumbra LP Coil SystemHCG · Special | Penumbra, Inc. | 11/20/2019SE |
| K180653 | Spartan eCoil SystemHCG · Traditional | Spartan Micro, Inc. | 12/04/2018SE |
| K173711 | Wallaby Avenir Coil SystemHCG · Traditional | Wallaby Medical, Inc. | 05/04/2018SE |
| K173614 | Penumbra Coil 400, Ruby Coil System, POD SystemHCG · Traditional | Penumbra, Inc. | 04/17/2018SE |
| K172390 | Optima Coil SystemHCG · Traditional | Blockade Medical, LLC (D.B.A. Balt Usa) | 02/18/2018SE |
| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | Codman & Shurtleff, Inc. | 09/25/2017SE |
| K170852 | POD Packing CoilHCG · Traditional | Penumbra, Inc. | 07/19/2017SE |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…HCG · Special | Codman & Shurtleff, Inc. | 07/14/2017SE |
| K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…HCG · Traditional | MicroVention, Inc. | 03/29/2017SE |
| K162704 | Axium Prime Detachable Coil SystemHCG · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 01/03/2017SE |
| K161452 | MicroPlex Coil System (MCS) - HyperSoft 3DHCG · Special | MicroVention, Inc. | 08/31/2016SE |
| K161367 | HydroCoil Embolic System (HES)HCG · Special | MicroVention, Inc. | 08/31/2016SE |
| K161429 | Target Detachable CoilsHCG · Special | Stryker Neurovascular | 06/22/2016SE |
| K153658 | Target Detachable CoilsHCG · Traditional | Stryker Neurovascular | 05/19/2016SE |
| K160832 | Penumbra Smart CoilHCG · Special | Penumbra, Inc. | 04/20/2016SE |
| K160096 | InZone Detachment SystemHCG · Special | Stryker Neurovascular | 02/19/2016SE |
| K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)HCG · Special | MicroVention, Inc. | 01/22/2016SE |
| K151447 | Axium Detachable Coil SystemHCG · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 07/28/2015SE |
| K151760 | Barricade Embolization Coil SystemHCG · Special | Blockade Medical | 07/27/2015SE |
| K151572 | Penumbra Smart CoilHCG · Special | Penumbra, Inc. | 07/10/2015SE |
| K150319 | Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/Xsft Stretch Resistant…HCG · Traditional | Codman & Shurtleff, Inc. | 06/12/2015SE |
| K143218 | Penumbra Smart CoilHCG · Traditional | Penumbra, Inc. | 03/18/2015SE |
| K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…HCG · Special | Codman & Shurtleff, Inc. | 12/24/2014SE |
| K142513 | Barricade Embolization Coil SystemHCG · Special | Blockade Medical | 11/13/2014SE |
| K141134 | Pod SystemHCG · Special | Penumbra, Inc. | 07/03/2014SE |
| K140104 | Barricade Embolization Coil SystemHCG · Special | Blockade Medical | 02/13/2014SE |
| K133310 | Axium Detachable Coil SystemHCG · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 01/10/2014SE |
| K132952 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)HCG · Special | MicroVention, Inc. | 12/19/2013SE |
| K132482 | Barricade Embolization Coil SystemHCG · Special | Blockade Medical | 10/10/2013SE |
| K131948 | Microplex Coil System (MCS)HCG · Special | MicroVention, Inc. | 10/04/2013SE |
| K132317 | Microplex Coil System (MCS), VFCHCG · Special | MicroVention, Inc. | 09/20/2013SE |
| K131475 | Barricade Embolization Coil SystemHCG · Special | Blockade Medical | 07/25/2013SE |
| K123338 | Barricade Embolization Coil SystemHCG · Traditional | Blockade Medical | 03/28/2013SE |
| K123560 | Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable…HCG · Special | Codman & Shurtleff, Inc. | 01/25/2013SE |
| K123377 | Target Detachable CoilHCG · Special | Stryker Neurovascular | 11/30/2012SE |
| K120908 | Hydrocoil Embolic System (Hes)HCG · Special | MicroVention, Inc. | 04/25/2012SE |
| K120850 | Target Detachable CoilHCG · Special | Stryker Neurovascular | 04/17/2012SE |
| K120686 | Orbit Galaxy G2 Microcoil Delivery SystemHCG · Special | Codman & Shurtleff, Inc. | 04/04/2012SE |
| K120330 | Penumbra Coil System/Penumbra Coil 400HCG · Traditional | Penumbra, Inc. | 04/02/2012SE |
| K113822 | Quadrasphere 30 to 60HCG · Special | Biosphere Medical, Inc. | 03/08/2012SE |
| K120274 | Deltamaxx 18 Microcoil SystemHCG · Special | Codman and Shurtleff, Inc. | 03/02/2012SE |
| K113457 | Hydrocoil Embolic System (Hes)HCG · Special | MicroVention, Inc. | 12/16/2011SE |
| K113412 | Target Detachable CoilHCG · Special | Stryker Neurovascular | 12/13/2011SE |
| K112181 | Hydrocoil(R) Embolic System (Hes)HCG · Special | MicroVention, Inc. | 12/01/2011SE |
| K112226 | Hydrocoil Embolic System (Hes)HCG · Special | MicroVention, Inc. | 09/29/2011SE |
| K111451 | Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…HCG · Traditional | MicroVention, Inc. | 09/20/2011SE |
| K112385 | Traget Detachable CoilHCG · Special | Stryker Neurovascular | 09/15/2011SE |
| K103758 | Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10HCG · Special | MicroVention, Inc. | 04/28/2011SE |
| K103355 | GDC 360 Deteachable CoilHCG · Traditional | Boston Scientific Corp | 02/16/2011SE |
| K103305 | Penumbra Embolization Coil SystemHCG · Traditional | Penumbra, Inc. | 01/26/2011SE |
| K103008 | Inzone Detachment SystemHCG · Special | Boston Scientific Corp | 12/10/2010SE |
| K102672 | Target Detachable CoilHCG · Special | Boston Scientific Corp | 10/15/2010SE |
| K093973 | Trufill DCS Orbit Detachable Coil SystemHCG · Traditional | Codman & Shurtleff, Inc. | 05/26/2010SE |
| K100454 | Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…HCG · Special | MicroVention, Inc. | 04/22/2010SE |
| K094018 | LC Bead Microspheres, Bead Block Compressible MicrospheresHCG · Special | Biocompatibles UK Limited | 04/16/2010SE |
| K093142 | Target Detachable Coils and Inzone Detachment SystemHCG · Traditional | Boston Scientific Corp | 02/04/2010SE |
| K093919 | Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VHCG · Special | MicroVention, Inc. | 01/21/2010SE |
| K093358 | Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VHCG · Traditional | MicroVention, Inc. | 01/15/2010SE |
| K092666 | Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250HCG · Special | Boston Scientific Corp | 09/30/2009SE |
| K091641 | Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)HCG · Special | MicroVention, Inc. | 06/30/2009SE |
| K090891 | Microplex Coil System-CosmosHCG · Traditional | MicroVention, Inc. | 06/22/2009SE |
| K090357 | Hydroframe (Hes)HCG · Traditional | MicroVention, Inc. | 04/10/2009SE |
| K090168 | Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415HCG · Special | MicroVention, Inc. | 03/12/2009SE |
| K090001 | V-Grip Plus Detachment Controller, Model VG503HCG · Special | MicroVention, Inc. | 03/05/2009SE |
| K083646 | Micrus Microcoli System, Deltaplush, Models CPL, DPLHCG · Special | Micrus Endovascular Corporation | 01/02/2009SE |
| K082739 | Micrus Microcoil Delivery SystemHCG · Special | Micrus Endovascular Corporation | 10/17/2008SE |
| K082461 | Bare Platinum Framing Coil, Model(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,1…HCG · Special | MicroVention, Inc. | 10/02/2008SE |
| K082324 | Trufill DCS SyringeHCG · Special | Cordis Neurovascular, Inc. | 09/12/2008SE |
| K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil SystemsHCG · Traditional | MicroVention, Inc. | 07/11/2008SE |
| K080379 | Micrus Microcoil System, Deltapaq 10 Stretch ResistantHCG · Traditional | Micrus Endovascular Corporation | 06/30/2008SE |
| K080437 | Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFHCG · Traditional | Micrus Endovascular Corporation | 05/08/2008SE |
| K080967 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II…HCG · Special | Cordis Neurovascular, Inc. | 05/02/2008SE |
| K073442 | Micrus Microcoil SystemsHCG · Traditional | Micrus Endovascular Corporation | 02/26/2008SE |
| K073419 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization…HCG · Traditional | Rj Medical, Inc. | 02/14/2008SE |
| K072173 | Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-Sr, Model SRCHCG · Special | Micrus Endovascular Corporation | 10/05/2007SE |
| K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)HCG · Special | Cordis Neurovascular, Inc. | 09/26/2007SE |
| K071634 | Modification To:Contour Se MicrospheresHCG · Special | Boston Scientific Corp | 07/12/2007SE |
| K070656 | Hydrocoil Embolic System (Hes)HCG · Traditional | MicroVention, Inc. | 06/15/2007SE |
| K071246 | Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC…HCG · Special | Micrus Endovascular Corporation | 06/01/2007SE |
| K060747 | FX Detachable Coil SystemHCG · Traditional | Micro Therapeutics, Inc. | 04/24/2007SE |
| K070707 | Micrus Microcoil SystemHCG · Special | Micrus Endovascular Corporation | 04/06/2007SE |
| K063653 | Micrus Microcoil System, Cashmere Model SRCHCG · Special | Micrus Endovascular Corporation | 01/17/2007SE |
| K052509 | M-Bolus Embolic MicrospheresHCG · Abbreviated | Scion Cardio-Vascular, Inc. | 12/11/2006SE |
| K063254 | The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemHCG · Traditional | Cordis Neurovascular, Inc. | 12/07/2006SE |
| K062036 | Micrus Microcoil System PRESIDIO-18, Model PC4HCG · Traditional | Micrus Endovascular Corporation | 08/25/2006SE |
| K060625 | Nexus Detachable Coil System, Morpheus 3D CSRHCG · Special | Micro Therapeutics, Inc. | 04/20/2006SE |
| K053548 | Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam…HCG · Traditional | Protein Polymer Technologies, Inc. | 01/30/2006SE |
| K053197 | Trufill DCS Orbit Detachable Coil System Line ExtensionHCG · Special | Cordis Neurovascular, Inc. | 12/15/2005SE |
| K053160 | Micrus Modified Microcoil 18-SYSTEM, Cerecyte, Model CSP & CheHCG · Special | Micrus Endovascular Corporation | 12/07/2005SE |
| K051560 | Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRHCG · Special | Micro Therapeutics, Inc. | 06/28/2005SE |
| K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)HCG · Traditional | MicroVention, Inc. | 06/28/2005SE |
| K051425 | Nexus Detachable Coil System, Helix Super Soft CSRHCG · Special | Micro Therapeutics, Inc. | 06/22/2005SE |
| K042297 | Ultra Ivalon and Ultra Drivalon Pva Embolization ParticlesHCG · Abbreviated | Acta Vascular Systems, Inc. | 06/01/2005SE |
| K050543 | Nexus Detachable Coil SystemHCG · Traditional | Micro Therapeutics, Inc. | 04/27/2005SE |
| K050700 | Matrix Stretch Resistant (SR) CoilsHCG · Special | Boston Scientific Corp | 04/15/2005SE |
| K042231 | Gelspheres Microspheres and Bead Block Compressible MicrospheresHCG · Traditional | Biocompatibles UK Limited | 11/12/2004SE |
| K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilHCG · Special | Boston Scientific Corp | 10/19/2004SE |
| K041649 | Sapphire NXT Detachable Coil SystemHCG · Special | Micro Therapeutics, Inc. | 07/16/2004SE |
| K041551 | Modification to: Hydrocoil Embolic System (Hes)HCG · Special | MicroVention, Inc. | 07/07/2004SE |
| K040694 | Modification to Sapphire Detachable Coil System (Tetris 3-D)HCG · Special | Micro Therapeutics, Inc. | 03/25/2004SE |
| K032619 | Microstat Pva Foam Embolization ParticlesHCG · Special | Surgica Corp. | 02/13/2004SE |
| K033813 | Micrus Modified Microcoil System, CerecyteHCG · Traditional | Micrus Corp. | 02/04/2004SE |
| K033761 | Gelspheres / Beadblock Compressible MicrospheresHCG · Traditional | Biocompatibles UK Limited | 02/04/2004SE |
| K033372 | Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple ModelsHCG · Traditional | Micro Therapeutics, Inc. | 01/09/2004SE |
| K033836 | Hydrocoil Embolic System (Hes)HCG · Special | MicroVention, Inc. | 12/30/2003SE |
| K032872 | Micrus Microcoil SystemHCG · Traditional | Micrus Corp. | 11/28/2003SE |
| K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)HCG · Traditional | MicroVention, Inc. | 10/22/2003SE |
| K032497 | Sapphire VDS Tension Safe Detachable Coil, E-3-12/3-T10-VTHCG · Special | Micro Therapeutics, Inc. | 09/25/2003SE |
| K032707 | Contour Se Microspheres (Syringe)HCG · Special | Boston Scientific Corp | 09/23/2003SE |
| K032553 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known AS Trufill DCS…HCG · Special | Cordis Neurovascular, Inc. | 09/23/2003SE |
| K032542 | Modification to Contour Se MicrospheresHCG · Special | Boston Scientific Corp | 09/16/2003SE |
| K031852 | Sapphire Detachable Fiber CoilsHCG · Traditional | Micro Therapeutics, Inc. | 08/20/2003SE |
| K031578 | Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRHCG · Traditional | Micrus Corp. | 08/01/2003SE |
| K031049 | Guglielmi Detachable Coil (GDC)HCG · Traditional | Boston Scientific, Target | 08/01/2003SE |
| K030392 | Sapphire Detachable Coil SystemHCG · Traditional | Micro Therapeutics, Inc. | 07/21/2003SE |
| K030963 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known AS the Trufill DCS…HCG · Traditional | Cordis Neurovascular, Inc. | 06/20/2003SE |
| K031168 | Matrix Stretch Resistant Detachable CoilHCG · Special | Boston Scientific, Target | 05/14/2003SE |
| K030475 | GDC Stretch Resistant Detachable CoilHCG · Special | Boston Scientific, Target | 03/14/2003SE |
| K023089 | Gelspheres Embolic AgentHCG · Traditional | Biocure, Inc. | 12/16/2002SE |
| K022420 | Micrus Stretch-Resistant Microcoil System, MSR01HCG · Traditional | Micrus Corp. | 10/22/2002SE |
| K022735 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink…HCG · Special | MicroVention, Inc. | 09/06/2002SE |
| K022427 | Contour Se MicrospheresHCG · Special | Boston Scientific Corp | 08/22/2002SE |
| K020434 | Microplex Coil System (MCS)HCG · Traditional | MicroVention, Inc. | 07/29/2002SE |
| K021914 | Microplex Coil Systems (MCS)HCG · Special | MicroVention, Inc. | 07/09/2002SE |
| K021494 | GDC Power Supply, Model GDC Power Supply: 451007-4HCG · Special | Boston Scientific, Target | 06/06/2002SE |
| K020033 | Maxistat Pva Foam Embolization ParticlesHCG · Special | Surgica Corp. | 05/31/2002SE |
| K014041 | Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known AS the Trufill DCS…HCG · Traditional | Cordis Neurovascular | 03/07/2002SE |
| K012985 | Matrix Detachable CoilsHCG · Traditional | Boston Scientific, Target | 01/31/2002SE |
| K012145 | Microplex Coil SystemHCG · Traditional | MicroVention, Inc. | 10/29/2001SE |
| K010026 | Embogold MicrosphereHCG · Special | Biosphere Medical, Inc. | 06/21/2001SE |
| K001678 | Pva Foam Embolization ParticlesHCG · Traditional | Surgica Corp. | 01/25/2001SE |
| K002056 | Micrus Microcoil Delivery System, MDS03HCG · Traditional | Micrus Corp. | 01/11/2001SE |
| K000651 | Detach 18 and Detach 11, Neurological Embolization Coil SystemHCG · Traditional | Cook, Inc. | 11/24/2000SE |
| K002181 | GDC Ultrasoft CoilHCG · Special | Boston Scientific, Target | 08/11/2000SE |
| K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables:…HCG · Special | Boston Scientific, Target | 05/03/2000SE |
| K991549 | Embosphere MicrospheresHCG · Traditional | Biosphere Medical | 04/26/2000SE |
| K993418 | Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilHCG · Traditional | Boston Scientific, Target | 01/21/2000SE |
| K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…HCG · Traditional | Boston Scientific, Target | 01/21/2000SE |
| K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-DIAMETER Stretch Resistant…HCG · Traditional | Boston Scientific, Target | 01/21/2000SE |
| K991139 | Guglielmi Detachable (GDC)HCG · Traditional | Boston Scientific, Target | 12/22/1999SE |
| K983483 | Vascular Occlusion SystemHCG · Traditional | Cordis Neurovascular, Inc. | 03/24/1999SE |
| K972881 | Ces Vascular Occlusion SystemHCG · Traditional | Cordis Neurovascular, Inc. | 06/04/1998SE |
| K964021 | Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)HCG · Traditional | Baxter Edwards | 03/27/1997SE |
| K965174 | Trufill Pva ParticlesHCG · Traditional | Cordis Neurovascular, Inc. | 03/21/1997SE |
| K964367 | Ces Vascular Occlusion SystemHCG · Traditional | Cordis Neurovascular, Inc. | 01/30/1997SE |
| K963307 | GDC Patient Return Electtrode Model 45021HCG · Traditional | Target Therapeutics | 12/17/1996SE |
| K962503 | Guglielmi Detachable CoilHCG · Traditional | Target Therapeutics | 09/20/1996SE |
| K961923 | Berenstein CoilHCG · Traditional | Target Therapeutics | 08/15/1996SE |
| K960705 | Guglielmi Detachable CoilHCG · Traditional | Target Therapeutics | 05/21/1996SE |
| K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)HCG · Traditional | Target Therapeutics | 09/08/1995SE |
| K951314 | Truefill Pva ParticlesHCG · Traditional | Cordis Neurovascular, Inc. | 08/08/1995SE |
| K944354 | Contour EmboliHCG · Traditional | Interventional Therapeutics Corp. | 12/13/1994SE |
| K913556 | Ivalon Embolization ParticlesHCG · Traditional | Ivalon | 04/13/1994SE |
| K914866 | Itc Contour Emboli, ModificationHCG · Traditional | Interventional Therapeutics Corp. | 11/09/1993SE |
| K925876 | Itc Bunji Platinum Embolization CoilHCG · Traditional | Interventional Therapeutics Corp. | 04/15/1993SE |
| K925523 | Itc Bunji Platinum Embolization CoilHCG · Traditional | Interventional Therapeutics Corp. | 03/23/1993SE |
| K920324 | Itc Bunji Coil (Modification)HCG · Traditional | Interventional Therapeutics Corp. | 07/29/1992SESP |
| K913312 | Helix Shaped Coils with Dacron Fibers, ModifiedHCG · Traditional | Target Therapeutics | 11/08/1991SE |
| K911779 | Helix Shaped Coils with Dacron Fibers, ModifiedHCG · Traditional | Target Therapeutics | 11/08/1991SE |
| K900723 | Itc Bunji CoilHCG · Traditional | Interventional Therapeutics Corp. | 02/19/1991SE |
| K901337 | Hilal Embolization Microcoil(Tm)HCG · Traditional | Cook, Inc. | 11/13/1990SE |
| K901721 | Modified Target Therapeutics CoilsHCG · Traditional | Target Therapeutics | 07/03/1990SE |
| K891688 | Coil and Coil Delivery SystemHCG · Traditional | Target Therapeutics | 09/22/1989SE |
| K871047 | Radiopaque Spherical Emboli (Rse)HCG · Traditional | Interventional Therapeutics Corp. | 05/22/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2552-2026 Class II | INZONE DETACHMENT SYSTEM, REF: M00345100950Embolization coil detachment system devices may experience premature battery drain causing devices to: 1)… | Stryker Neurovascular | 04/06/2026Open, Classified |
| Z-0434-2026 Class I | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM…Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke… | Cerenovus Inc | 10/02/2025Open, Classified |
| Z-1988-2025 Class II | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK…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-1041-2024 Class II | Neurovascular embolization device. The Optima Coil System is a series specialized coils…Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube.… | Balt USA, LLC | 01/03/2024Open, Classified |
| Z-0103-2023 Class II | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in…Product pouch label does not match up with carton label | Balt USA, LLC | 09/07/2022Open, Classified |
| Z-1680-2022 Class II | Optima Coil System Model OPTI0520CSF10. For endovascular embolization.Products were released to customers prior to the approval and release of a test report authorizing the use… | Balt USA, LLC | 07/26/2022Open, Classified |
| Z-1261-2022 Class II | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF…Due to incorrect size and configuration labeling of the detachable coil system. | Micro Therapeutics, Inc. | 04/27/2022Open, Classified |
| Z-0660-2022 Class II | The Optima Coil System consists of an implantable embolization coil comprised of a…Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to… | Balt USA, LLC | 01/04/2022Open, Classified |
| Z-1407-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1406-2020 Class II | MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1405-2020 Class II | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1404-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1403-2020 Class II | MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1402-2020 Class II | MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1401-2020 Class II | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1400-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1399-2020 Class II | MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1398-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1397-2020 Class II | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1396-2020 Class II | MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1395-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1394-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1393-2020 Class II | MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-1392-2020 Class II | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization…The devices may be missing the implant coil. | Microvention, Inc. | 11/22/2019Terminated |
| Z-2280-2019 Class II | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).Incorrect coil length on the label | Codman & Shurtleff Inc | 05/16/2019Terminated |
| Z-2187-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2186-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2185-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2184-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2183-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2182-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2181-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2180-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2179-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2178-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2177-2016 Class II | Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2176-2016 Class II | Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology:…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2175-2016 Class II | Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology:…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2174-2016 Class II | Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2173-2016 Class II | Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology:…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2172-2016 Class II | Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology:…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2171-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2170-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2169-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2168-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2167-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2166-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2165-2016 Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2164-2016 Class II | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |
| Z-2163-2016 Class II | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530…Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended… | Stryker Neurovascular | 06/06/2016Terminated |