Atlas FDA

HCG

186 FDA 510(k) clearances · Product code

74 daysmedian time to decision
194 days90th percentile
186clearances measured

FDA profile

Official device name
Device, Neurovascular Embolization
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5950
Medical specialty
Neurology
Flags
Implant
Adverse events (MAUDE)
2021: 2,268 · 2022: 663 · 2023: 568 · 2024: 552 · 2025: 545 · 2026: 309
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Target Xtra Detachable Coil (K261772)Stryker Neurovscular2026-06-24
Numen™ Helia Coil Embolization System; NumenFR™ Detachment System (K260351)MicroPort NeuroTech (Shanghai) Co., Ltd.2026-05-20
Optima Coil System (OptiOne Coil System) (K254221)Balt USA, LLC2026-01-27
Target Detachable Coil (K252694)Stryker Neurovascular2025-12-11
InZone IST Detachment System; IZDS Connecting Cable (K251832)Stryker Neurovascular2025-10-17
Optima Coil System (Optima Packing Coil System) (K252700)Balt USA, LLC2025-09-26
Numen™ Coil Embolization System; NumenFR™ Detachment System (K242154)MicroPort NeuroTech (Shanghai) Co., Ltd.2024-09-30
Optima Coil System (OptiBlock Line Extension) (K242582)Balt USA, LLC2024-09-27
Target Detachable Coils (K242243)Stryker Neurovscular2024-08-29
Numen Coil Embolization System; NumenFR Detachment System (K232955)MicroPort NeuroTech (Shanghai) Co., Ltd.2024-01-10
Axium Detachable Coil; Axium Prime Detachable Coil (K233420)Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular2023-11-07
Penumbra LP Coil System (K230284)Penumbra, Inc.2023-10-25
Target Tetra Detachable Coils (K222533)Stryker Neurovascular2022-12-14
Optima Coil System (K223386)Balt USA, LLC2022-12-06
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems (K220040)Medos International SARL2022-07-14
InZone Detachment System (K212455)Stryker Neurovascular2021-11-16
Numen Coil Embolization System; NumenFR Detachment System (K203625)MicroPort NeuroTech (Shanghai) Co., Ltd.2021-09-01
Axium Detachable Coil; Axium Prime Detachable Coil (K203432)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-07-07
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems (K211344)Medos International SARL2021-05-28
i-ED COIL System (K210638)Kaneka Medical America, LLC2021-03-26
i-ED COIL (K192068)Kaneka Pharma America, LLC2020-04-25
Optima Coil System (K200030)Balt USA, LLC2020-02-01
Penumbra LP Coil System (K192955)Penumbra, Inc.2019-11-20
Spartan eCoil System (K180653)Spartan Micro, Inc.2018-12-04
Wallaby Avenir Coil System (K173711)Wallaby Medical, Inc.2018-05-04
Penumbra Coil 400, Ruby Coil System, POD System (K173614)Penumbra, Inc.2018-04-17
Optima Coil System (K172390)Blockade Medical, LLC (D.B.A. Balt Usa)2018-02-18
GALAXY G3 Mini Microcoil Delivery System (K171862)Codman & Shurtleff, Inc.2017-09-25
POD Packing Coil (K170852)Penumbra, Inc.2017-07-19
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 (K171747)Codman & Shurtleff, Inc.2017-07-14
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System (K162999)MicroVention, Inc.2017-03-29
Axium Prime Detachable Coil System (K162704)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2017-01-03
HydroCoil Embolic System (HES) (K161367)MicroVention, Inc.2016-08-31
MicroPlex Coil System (MCS) - HyperSoft 3D (K161452)MicroVention, Inc.2016-08-31
Target Detachable Coils (K161429)Stryker Neurovascular2016-06-22
Target Detachable Coils (K153658)Stryker Neurovascular2016-05-19
Penumbra Smart Coil (K160832)Penumbra, Inc.2016-04-20
InZone Detachment System (K160096)Stryker Neurovascular2016-02-19
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) (K153594)MicroVention, Inc.2016-01-22
Axium Detachable Coil System (K151447)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2015-07-28
Barricade Embolization Coil System (K151760)Blockade Medical2015-07-27
Penumbra Smart Coil (K151572)Penumbra, Inc.2015-07-10
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS (K150319)Codman & Shurtleff, Inc.2015-06-12
Penumbra Smart Coil (K143218)Penumbra, Inc.2015-03-18
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable (K142429)Codman & Shurtleff, Inc.2014-12-24
Barricade Embolization Coil System (K142513)Blockade Medical2014-11-13
POD SYSTEM (K141134)Penumbra, Inc.2014-07-03
BARRICADE EMBOLIZATION COIL SYSTEM (K140104)Blockade Medical2014-02-13
AXIUM DETACHABLE COIL SYSTEM (K133310)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2014-01-10
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) (K132952)MicroVention, Inc.2013-12-19
BARRICADE EMBOLIZATION COIL SYSTEM (K132482)Blockade Medical2013-10-10
MICROPLEX COIL SYSTEM (MCS) (K131948)MicroVention, Inc.2013-10-04
MICROPLEX COIL SYSTEM (MCS), VFC (K132317)MicroVention, Inc.2013-09-20
BARRICADE EMBOLIZATION COIL SYSTEM (K131475)Blockade Medical2013-07-25
BARRICADE EMBOLIZATION COIL SYSTEM (K123338)Blockade Medical2013-03-28
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM (K123560)Codman & Shurtleff, Inc.2013-01-25
TARGET DETACHABLE COIL (K123377)Stryker Neurovascular2012-11-30
HYDROCOIL EMBOLIC SYSTEM (HES) (K120908)MicroVention, Inc.2012-04-25
TARGET DETACHABLE COIL (K120850)Stryker Neurovascular2012-04-17
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM (K120686)Codman & Shurtleff, Inc.2012-04-04
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 (K120330)Penumbra, Inc.2012-04-02
QUADRASPHERE 30 TO 60 (K113822)Biosphere Medical, Inc.2012-03-08
DELTAMAXX 18 MICROCOIL SYSTEM (K120274)Codman and Shurtleff, Inc.2012-03-02
HYDROCOIL EMBOLIC SYSTEM (HES) (K113457)MicroVention, Inc.2011-12-16
TARGET DETACHABLE COIL (K113412)Stryker Neurovascular2011-12-13
HYDROCOIL(R) EMBOLIC SYSTEM (HES) (K112181)MicroVention, Inc.2011-12-01
HYDROCOIL EMBOLIC SYSTEM (HES) (K112226)MicroVention, Inc.2011-09-29
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX (K111451)MicroVention, Inc.2011-09-20
TRAGET DETACHABLE COIL (K112385)Stryker Neurovascular2011-09-15
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 (K103758)MicroVention, Inc.2011-04-28
GDC 360 DETEACHABLE COIL (K103355)Boston Scientific Corp2011-02-16
PENUMBRA EMBOLIZATION COIL SYSTEM (K103305)Penumbra, Inc.2011-01-26
INZONE DETACHMENT SYSTEM (K103008)Boston Scientific Corp2010-12-10
TARGET DETACHABLE COIL (K102672)Boston Scientific Corp2010-10-15
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K093973)Codman & Shurtleff, Inc.2010-05-26
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V (K100454)MicroVention, Inc.2010-04-22
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES (K094018)Biocompatibles UK Limited2010-04-16
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM (K093142)Boston Scientific Corp2010-02-04
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V (K093919)MicroVention, Inc.2010-01-21
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V (K093358)MicroVention, Inc.2010-01-15
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 (K092666)Boston Scientific Corp2009-09-30
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) (K091641)MicroVention, Inc.2009-06-30
MICROPLEX COIL SYSTEM-COSMOS (K090891)MicroVention, Inc.2009-06-22
HYDROFRAME (HES) (K090357)MicroVention, Inc.2009-04-10
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 (K090168)MicroVention, Inc.2009-03-12
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503 (K090001)MicroVention, Inc.2009-03-05
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL (K083646)Micrus Endovascular Corporation2009-01-02
MICRUS MICROCOIL DELIVERY SYSTEM (K082739)Micrus Endovascular Corporation2008-10-17
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B (K082461)MicroVention, Inc.2008-10-02
TRUFILL DCS SYRINGE (K082324)Cordis Neurovascular, Inc.2008-09-12
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS (K080666)MicroVention, Inc.2008-07-11
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT (K080379)Micrus Endovascular Corporation2008-06-30
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF (K080437)Micrus Endovascular Corporation2008-05-08
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT (K080967)Cordis Neurovascular, Inc.2008-05-02
MICRUS MICROCOIL SYSTEMS (K073442)Micrus Endovascular Corporation2008-02-26
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES (K073419)Rj Medical, Inc.2008-02-14
MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC (K072173)Micrus Endovascular Corporation2007-10-05
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) (K071962)Cordis Neurovascular, Inc.2007-09-26
MODIFICATION TO:CONTOUR SE MICROSPHERES (K071634)Boston Scientific Corp2007-07-12
HYDROCOIL EMBOLIC SYSTEM (HES) (K070656)MicroVention, Inc.2007-06-15
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