Device, Neurovascular Embolization
FDA product code HCG · 177 cleared devices
Class 2
Neurology
- Regulation
- 21 CFR 882.5950
- Review panel
- NE
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1987-05-22 – 2026-08-14
HCG
2026-08-14
HCG
2026-06-24
Target Xtra Detachable Coil
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HCG
2026-05-20
Numen™ Helia Coil Embolization System; NumenFR™ Detachment System
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HCG
2026-01-27
Optima Coil System (OptiOne Coil System)
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HCG
2025-12-11
Target Detachable Coil
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HCG
2025-10-17
InZone IST Detachment System; IZDS Connecting Cable
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HCG
2025-09-26
Optima Coil System (Optima Packing Coil System)
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HCG
2024-09-30
Numen™ Coil Embolization System; NumenFR™ Detachment System
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HCG
2024-09-27
Optima Coil System (OptiBlock Line Extension)
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HCG
2024-08-29
Target Detachable Coils
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HCG
2024-01-10
Numen Coil Embolization System; NumenFR Detachment System
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HCG
2023-11-07
Axium Detachable Coil; Axium Prime Detachable Coil
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HCG
2023-10-25
Penumbra LP Coil System
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HCG
2022-12-14
Target Tetra Detachable Coils
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HCG
2022-12-06
Optima Coil System
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HCG
2022-07-14
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
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HCG
2021-11-16
InZone Detachment System
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HCG
2021-09-01
Numen Coil Embolization System; NumenFR Detachment System
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HCG
2021-07-07
Axium Detachable Coil; Axium Prime Detachable Coil
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HCG
2021-05-28
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
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HCG
2021-03-26
i-ED COIL System
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HCG
2020-04-25
i-ED COIL
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HCG
2020-02-01
Optima Coil System
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HCG
2019-11-20
Penumbra LP Coil System
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HCG
2018-12-04
Spartan eCoil System
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HCG
2018-05-04
Wallaby Avenir Coil System
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HCG
2018-04-17
Penumbra Coil 400, Ruby Coil System, POD System
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HCG
2018-02-18
Optima Coil System
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HCG
2017-09-25
GALAXY G3 Mini Microcoil Delivery System
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HCG
2017-07-19
POD Packing Coil
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HCG
2017-07-14
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
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HCG
2017-03-29
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
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HCG
2017-01-03
Axium Prime Detachable Coil System
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HCG
2016-08-31
MicroPlex Coil System (MCS) - HyperSoft 3D
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HCG
2016-08-31
HydroCoil Embolic System (HES)
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HCG
2016-06-22
Target Detachable Coils
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HCG
2016-05-19
Target Detachable Coils
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HCG
2016-04-20
Penumbra Smart Coil
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HCG
2016-02-19
InZone Detachment System
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HCG
2016-01-22
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
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HCG
2013-12-19
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
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HCG
2013-10-10
BARRICADE EMBOLIZATION COIL SYSTEM
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HCG
2013-10-04
MICROPLEX COIL SYSTEM (MCS)
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HCG
2013-09-20
MICROPLEX COIL SYSTEM (MCS), VFC
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HCG
2013-07-25
BARRICADE EMBOLIZATION COIL SYSTEM
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HCG
2013-03-28
BARRICADE EMBOLIZATION COIL SYSTEM
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HCG
2013-01-25
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
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HCG
2012-11-30
TARGET DETACHABLE COIL
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HCG
2012-04-25
HYDROCOIL EMBOLIC SYSTEM (HES)
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HCG
2012-04-17
TARGET DETACHABLE COIL
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HCG
2012-04-04
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
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HCG
2012-04-02
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
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HCG
2012-03-08
QUADRASPHERE 30 TO 60
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HCG
2012-03-02
DELTAMAXX 18 MICROCOIL SYSTEM
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HCG
2011-12-16
HYDROCOIL EMBOLIC SYSTEM (HES)
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HCG
2011-12-13
TARGET DETACHABLE COIL
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HCG
2011-12-01
HYDROCOIL(R) EMBOLIC SYSTEM (HES)
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HCG
2011-09-29
HYDROCOIL EMBOLIC SYSTEM (HES)
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HCG
2011-09-20
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
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HCG
2011-09-15
TRAGET DETACHABLE COIL
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HCG
2011-04-28
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
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HCG
2011-02-16
GDC 360 DETEACHABLE COIL
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HCG
2011-01-26
PENUMBRA EMBOLIZATION COIL SYSTEM
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HCG
2010-12-10
INZONE DETACHMENT SYSTEM
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HCG
2010-10-15
TARGET DETACHABLE COIL
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HCG
2010-05-26
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
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HCG
2010-04-22
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
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HCG
2010-04-16
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
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HCG
2010-02-04
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
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HCG
2010-01-21
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
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HCG
2010-01-15
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
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HCG
2009-09-30
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
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HCG
2009-06-30
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
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HCG
2009-06-22
MICROPLEX COIL SYSTEM-COSMOS
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HCG
2009-04-10
HYDROFRAME (HES)
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HCG
2009-03-12
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
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HCG
2009-03-05
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
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HCG
2009-01-02
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL
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HCG
2008-10-17
MICRUS MICROCOIL DELIVERY SYSTEM
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HCG
2008-10-02
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
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HCG
2008-09-12
TRUFILL DCS SYRINGE
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HCG
2008-07-11
HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
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HCG
2008-06-30
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT
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HCG
2008-05-08
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF
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HCG
2008-05-02
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT
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HCG
2008-02-26
MICRUS MICROCOIL SYSTEMS
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HCG
2008-02-14
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES
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HCG
2007-10-05
MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC
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HCG
2007-09-26
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)
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HCG
2007-07-12
MODIFICATION TO:CONTOUR SE MICROSPHERES
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HCG
2007-06-15
HYDROCOIL EMBOLIC SYSTEM (HES)
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HCG
2007-06-01
MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
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HCG
2007-04-24
FX DETACHABLE COIL SYSTEM
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HCG
2007-04-06
MICRUS MICROCOIL SYSTEM
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HCG
2007-01-17
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC
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HCG
2006-12-11
M-BOLUS EMBOLIC MICROSPHERES
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HCG
2006-12-07
THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
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HCG
2006-08-25
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4
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HCG
2006-04-20
NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR
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HCG
2006-01-30
MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
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