FDA Product Code
FDA Product Code HCG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5950
510(k) Clearances — 187 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262419 | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | Cerenovus, Inc. | 2026-08-14 | Special | PDF ↗ |
| K261772 | Target Xtra Detachable Coil | Stryker Neurovscular | 2026-06-24 | Special | PDF ↗ |
| K260351 | Numen Helia Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2026-05-20 | Special | PDF ↗ |
| K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | 2026-01-27 | Special | PDF ↗ |
| K252694 | Target Detachable Coil | Stryker Neurovascular | 2025-12-11 | Traditional | PDF ↗ |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | 2025-10-17 | Special | PDF ↗ |
| K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | 2025-09-26 | Special | PDF ↗ |
| K242154 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-09-30 | Special | PDF ↗ |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | 2024-09-27 | Special | PDF ↗ |
| K242243 | Target Detachable Coils | Stryker Neurovscular | 2024-08-29 | Special | PDF ↗ |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-01-10 | Special | PDF ↗ |
| K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2023-11-07 | Special | PDF ↗ |
| K230284 | Penumbra LP Coil System | Penumbra, Inc. | 2023-10-25 | Traditional | PDF ↗ |
| K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | 2022-12-14 | Traditional | PDF ↗ |
| K223386 | Optima Coil System | Balt USA, LLC | 2022-12-06 | Special | PDF ↗ |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems | Medos International SARL | 2022-07-14 | Traditional | PDF ↗ |
| K212455 | InZone Detachment System | Stryker Neurovascular | 2021-11-16 | Traditional | PDF ↗ |
| K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021-09-01 | Traditional | PDF ↗ |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-07 | Traditional | PDF ↗ |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems | Medos International SARL | 2021-05-28 | Special | PDF ↗ |
| K210638 | i-ED COIL System | Kaneka Medical America, LLC | 2021-03-26 | Special | PDF ↗ |
| K192068 | i-ED COIL | Kaneka Pharma America, LLC | 2020-04-25 | Traditional | PDF ↗ |
| K200030 | Optima Coil System | Balt USA, LLC | 2020-02-01 | Special | PDF ↗ |
| K192955 | Penumbra LP Coil System | Penumbra, Inc. | 2019-11-20 | Special | PDF ↗ |
| K180653 | Spartan eCoil System | Spartan Micro, Inc. | 2018-12-04 | Traditional | PDF ↗ |
| K173711 | Wallaby Avenir Coil System | Wallaby Medical, Inc. | 2018-05-04 | Traditional | PDF ↗ |
| K173614 | Penumbra Coil 400, Ruby Coil System, POD System | Penumbra, Inc. | 2018-04-17 | Traditional | PDF ↗ |
| K172390 | Optima Coil System | Blockade Medical, LLC (D.B.A. Balt Usa) | 2018-02-18 | Traditional | PDF ↗ |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | Codman & Shurtleff, Inc. | 2017-09-25 | Traditional | PDF ↗ |
| K170852 | POD Packing Coil | Penumbra, Inc. | 2017-07-19 | Traditional | PDF ↗ |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System | Codman & Shurtleff, Inc. | 2017-07-14 | Special | PDF ↗ |
| K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System | MicroVention, Inc. | 2017-03-29 | Traditional | PDF ↗ |
| K162704 | Axium Prime Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-01-03 | Traditional | PDF ↗ |
| K161367 | HydroCoil Embolic System (HES) | MicroVention, Inc. | 2016-08-31 | Special | PDF ↗ |
| K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D | MicroVention, Inc. | 2016-08-31 | Special | PDF ↗ |
| K161429 | Target Detachable Coils | Stryker Neurovascular | 2016-06-22 | Special | PDF ↗ |
| K153658 | Target Detachable Coils | Stryker Neurovascular | 2016-05-19 | Traditional | PDF ↗ |
| K160832 | Penumbra Smart Coil | Penumbra, Inc. | 2016-04-20 | Special | PDF ↗ |
| K160096 | InZone Detachment System | Stryker Neurovascular | 2016-02-19 | Special | PDF ↗ |
| K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | MicroVention, Inc. | 2016-01-22 | Special | PDF ↗ |
| K151447 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2015-07-28 | Special | PDF ↗ |
| K151760 | Barricade Embolization Coil System | Blockade Medical | 2015-07-27 | Special | PDF ↗ |
| K151572 | Penumbra Smart Coil | Penumbra, Inc. | 2015-07-10 | Special | PDF ↗ |
| K150319 | MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS | Codman & Shurtleff, Inc. | 2015-06-12 | Traditional | PDF ↗ |
| K143218 | Penumbra Smart Coil | Penumbra, Inc. | 2015-03-18 | Traditional | PDF ↗ |
| K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable | Codman & Shurtleff, Inc. | 2014-12-24 | Special | PDF ↗ |
| K142513 | Barricade Embolization Coil System | Blockade Medical | 2014-11-13 | Special | PDF ↗ |
| K141134 | POD SYSTEM | Penumbra, Inc. | 2014-07-03 | Special | PDF ↗ |
| K140104 | BARRICADE EMBOLIZATION COIL SYSTEM | Blockade Medical | 2014-02-13 | Special | PDF ↗ |
| K133310 | AXIUM DETACHABLE COIL SYSTEM | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2014-01-10 | Special | PDF ↗ |
| K132952 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2013-12-19 | Special | PDF ↗ |
| K132482 | BARRICADE EMBOLIZATION COIL SYSTEM | Blockade Medical | 2013-10-10 | Special | PDF ↗ |
| K131948 | MICROPLEX COIL SYSTEM (MCS) | MicroVention, Inc. | 2013-10-04 | Special | PDF ↗ |
| K132317 | MICROPLEX COIL SYSTEM (MCS), VFC | MicroVention, Inc. | 2013-09-20 | Special | PDF ↗ |
| K131475 | BARRICADE EMBOLIZATION COIL SYSTEM | Blockade Medical | 2013-07-25 | Special | PDF ↗ |
| K123338 | BARRICADE EMBOLIZATION COIL SYSTEM | Blockade Medical | 2013-03-28 | Traditional | PDF ↗ |
| K123560 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM | Codman & Shurtleff, Inc. | 2013-01-25 | Special | PDF ↗ |
| K123377 | TARGET DETACHABLE COIL | Stryker Neurovascular | 2012-11-30 | Special | PDF ↗ |
| K120908 | HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2012-04-25 | Special | PDF ↗ |
| K120850 | TARGET DETACHABLE COIL | Stryker Neurovascular | 2012-04-17 | Special | PDF ↗ |
| K120686 | ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM | Codman & Shurtleff, Inc. | 2012-04-04 | Special | PDF ↗ |
| K120330 | PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 | Penumbra, Inc. | 2012-04-02 | Traditional | PDF ↗ |
| K113822 | QUADRASPHERE 30 TO 60 | Biosphere Medical, Inc. | 2012-03-08 | Special | PDF ↗ |
| K120274 | DELTAMAXX 18 MICROCOIL SYSTEM | Codman and Shurtleff, Inc. | 2012-03-02 | Special | PDF ↗ |
| K113457 | HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2011-12-16 | Special | PDF ↗ |
| K113412 | TARGET DETACHABLE COIL | Stryker Neurovascular | 2011-12-13 | Special | PDF ↗ |
| K112181 | HYDROCOIL(R) EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2011-12-01 | Special | PDF ↗ |
| K112226 | HYDROCOIL EMBOLIC SYSTEM (HES) | MicroVention, Inc. | 2011-09-29 | Special | PDF ↗ |
| K111451 | MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX | MicroVention, Inc. | 2011-09-20 | Traditional | PDF ↗ |
| K112385 | TRAGET DETACHABLE COIL | Stryker Neurovascular | 2011-09-15 | Special | PDF ↗ |
| K103758 | MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 | MicroVention, Inc. | 2011-04-28 | Special | PDF ↗ |
| K103355 | GDC 360 DETEACHABLE COIL | Boston Scientific Corp | 2011-02-16 | Traditional | PDF ↗ |
| K103305 | PENUMBRA EMBOLIZATION COIL SYSTEM | Penumbra, Inc. | 2011-01-26 | Traditional | PDF ↗ |
| K103008 | INZONE DETACHMENT SYSTEM | Boston Scientific Corp | 2010-12-10 | Special | PDF ↗ |
| K102672 | TARGET DETACHABLE COIL | Boston Scientific Corp | 2010-10-15 | Special | PDF ↗ |
| K093973 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | Codman & Shurtleff, Inc. | 2010-05-26 | Traditional | PDF ↗ |
| K100454 | HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V | MicroVention, Inc. | 2010-04-22 | Special | PDF ↗ |
| K094018 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | Biocompatibles UK Limited | 2010-04-16 | Special | PDF ↗ |
| K093142 | TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM | Boston Scientific Corp | 2010-02-04 | Traditional | PDF ↗ |
| K093919 | MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V | MicroVention, Inc. | 2010-01-21 | Special | PDF ↗ |
| K093358 | MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V | MicroVention, Inc. | 2010-01-15 | Traditional | PDF ↗ |
| K092666 | INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 | Boston Scientific Corp | 2009-09-30 | Special | PDF ↗ |
| K091641 | HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) | MicroVention, Inc. | 2009-06-30 | Special | PDF ↗ |
| K090891 | MICROPLEX COIL SYSTEM-COSMOS | MicroVention, Inc. | 2009-06-22 | Traditional | PDF ↗ |
| K090357 | HYDROFRAME (HES) | MicroVention, Inc. | 2009-04-10 | Traditional | PDF ↗ |
| K090168 | AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 | MicroVention, Inc. | 2009-03-12 | Special | PDF ↗ |
| K090001 | V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 | MicroVention, Inc. | 2009-03-05 | Special | PDF ↗ |
| K083646 | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL | Micrus Endovascular Corporation | 2009-01-02 | Special | PDF ↗ |
| K082739 | MICRUS MICROCOIL DELIVERY SYSTEM | Micrus Endovascular Corporation | 2008-10-17 | Special | PDF ↗ |
| K082461 | BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B | MicroVention, Inc. | 2008-10-02 | Special | PDF ↗ |
| K082324 | TRUFILL DCS SYRINGE | Cordis Neurovascular, Inc. | 2008-09-12 | Special | PDF ↗ |
| K080666 | HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS | MicroVention, Inc. | 2008-07-11 | Traditional | PDF ↗ |
| K080379 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT | Micrus Endovascular Corporation | 2008-06-30 | Traditional | PDF ↗ |
| K080437 | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF | Micrus Endovascular Corporation | 2008-05-08 | Traditional | PDF ↗ |
| K080967 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT | Cordis Neurovascular, Inc. | 2008-05-02 | Special | PDF ↗ |
| K073442 | MICRUS MICROCOIL SYSTEMS | Micrus Endovascular Corporation | 2008-02-26 | Traditional | PDF ↗ |
| K073419 | PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES | Rj Medical, Inc. | 2008-02-14 | Traditional | PDF ↗ |
| K072173 | MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC | Micrus Endovascular Corporation | 2007-10-05 | Special | PDF ↗ |
| K071962 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) | Cordis Neurovascular, Inc. | 2007-09-26 | Special | PDF ↗ |
| K071634 | MODIFICATION TO:CONTOUR SE MICROSPHERES | Boston Scientific Corp | 2007-07-12 | Special | PDF ↗ |
Product code HCG · Class II · Neurology. Data: openFDA.