ClearanceBrief
Panels › Neurology › Product code HCG · Class 2

Device, Neurovascular Embolization

Regulation 882.5950

5510(k)s in 12 months (187 all time)
2recalls in 12 months (68 all time)
67recalls that name a 510(k)
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Top companies in HCG

DateFirm and productCodeLinked 510(k)
Jun 24, 2026Stryker Neurovascular
INZONE DETACHMENT SYSTEM, REF: M00345100950
Open, Classified
HCGK212455
Nov 13, 2025Cerenovus Inc
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX1
Open, Classified
HCGK220040
Jun 18, 2025BALT USA, LLC
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905
Open, Classified
HCGK172390
K200030
Feb 8, 2024BALT USA, LLC
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and o
Open, Classified
HCGK172390
K200030 +1
Oct 20, 2022BALT USA, LLC
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Open, Classified
HCGK172390
K200030
Jul 26, 2022BALT USA, LLC
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Open, Classified
HCGK172390
K200030
Apr 27, 2022Micro Therapeutics, Inc.
AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Open, Classified
HCGK203432
Jan 4, 2022BALT USA, LLC
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a
Open, Classified
HCGK200030
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS
Terminated
HCGK050954
K091641 +3
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC03
Terminated
HCGK050954
K131948 +3
Nov 22, 2019Microvention, Inc.
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V,
Terminated
HCGK050954
K091641 +3
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 10061
Terminated
HCGK050954
K131948 +2
Nov 22, 2019Microvention, Inc.
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA,
Terminated
HCGK050954
K090357 +3
Nov 22, 2019Microvention, Inc.
MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V
Terminated
HCGK050954
K090357 +4
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Us
Terminated
HCGK050954
K131948 +2
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100
Terminated
HCGK050954
K131948 +2
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451
Terminated
HCGK050954
K090891 +3
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 10051
Terminated
HCGK050954
K090891 +4
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S
Terminated
HCGK050954
K091641 +3
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also int
Terminated
HCGK050954
K131948 +2
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HC
Terminated
HCGK050954
K091641 +3
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620
Terminated
HCGK050954
K131948 +2
Nov 22, 2019Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 10
Terminated
HCGK050954
K091641 +4
Nov 22, 2019Microvention, Inc.
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 1001
Terminated
HCGK050954
K091641 +3
May 16, 2019Codman & Shurtleff Inc
GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
Terminated
HCGK171862
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalit
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorma
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorma
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorm
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnor
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorma
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormal
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalit
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalit
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorm
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnor
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnor
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorm
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorm
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnorma
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormal
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalit
Terminated
HCGK113412
K153658
Jul 11, 2016Stryker Neurovascular
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormali
Terminated
HCGK113412
K153658

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