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)
Top companies in HCG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | Stryker Neurovascular INZONE DETACHMENT SYSTEM, REF: M00345100950 Open, Classified |
HCG | K212455 |
| Nov 13, 2025 | Cerenovus 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 |
HCG | K220040 |
| Jun 18, 2025 | BALT USA, LLC Optima Coil System REFs/UDI-DI codes:
OPTI0156BLK 00810068568875
OPTI0158BLK 00810068568882
OPTI0103BLK 00810068568851
OPTI0258BLK 00810068568929
OPTI0212BLK 00810068568912
OPTI0206BLK 00810068568905
Open, Classified |
HCG | K172390 K200030 |
| Feb 8, 2024 | BALT 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 |
HCG | K172390 K200030 +1 |
| Oct 20, 2022 | BALT USA, LLC Optima Coil System
Model Number OPTI0208CSS10,
Model Number OPTI0308CSS10. Used in endovascular procedures. Open, Classified |
HCG | K172390 K200030 |
| Jul 26, 2022 | BALT USA, LLC Optima Coil System Model OPTI0520CSF10. For endovascular embolization. Open, Classified |
HCG | K172390 K200030 |
| Apr 27, 2022 | Micro Therapeutics, Inc. AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX;
Axium Detachable Coil System REF QC-10-30-3D; Open, Classified |
HCG | K203432 |
| Jan 4, 2022 | BALT 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 |
HCG | K200030 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K091641 +3 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K131948 +3 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K091641 +3 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K090357 +3 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K090357 +4 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K090891 +3 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K090891 +4 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K091641 +3 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K091641 +3 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K091641 +4 |
| Nov 22, 2019 | Microvention, 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 |
HCG | K050954 K091641 +3 |
| May 16, 2019 | Codman & Shurtleff Inc GALAXY G3 Mini Microcoil Delivery System
Product No: GLM915030 (3 cm). Terminated |
HCG | K171862 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
| Jul 11, 2016 | Stryker 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 |
HCG | K113412 K153658 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.