Product code HCG
- Device name
- Device, Neurovascular Embolization
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5950
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260351 | Numen™ Helia Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2026-05-20 |
| K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | 2026-01-27 |
| K252694 | Target Detachable Coil | Stryker Neurovascular | 2025-12-11 |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | 2025-10-17 |
| K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | 2025-09-26 |
| K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-09-30 |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | 2024-09-27 |
| K242243 | Target Detachable Coils | Stryker Neurovscular | 2024-08-29 |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024-01-10 |
| K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2023-11-07 |
| K230284 | Penumbra LP Coil System | Penumbra, Inc. | 2023-10-25 |
| K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | 2022-12-14 |
| K223386 | Optima Coil System | Balt USA, LLC | 2022-12-06 |
| 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 |
| K212455 | InZone Detachment System | Stryker Neurovascular | 2021-11-16 |
| K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021-09-01 |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-07 |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems | Medos International SARL | 2021-05-28 |
| K210638 | i-ED COIL System | Kaneka Medical America, LLC | 2021-03-26 |
| K192068 | i-ED COIL | Kaneka Pharma America, LLC | 2020-04-25 |
| K200030 | Optima Coil System | Balt USA, LLC | 2020-02-01 |
| K192955 | Penumbra LP Coil System | Penumbra, Inc. | 2019-11-20 |
| K180653 | Spartan eCoil System | Spartan Micro, Inc. | 2018-12-04 |
| K173711 | Wallaby Avenir Coil System | Wallaby Medical, Inc. | 2018-05-04 |
| K173614 | Penumbra Coil 400, Ruby Coil System, POD System | Penumbra, Inc. | 2018-04-17 |
| K172390 | Optima Coil System | Blockade Medical, LLC (D.B.A. Balt Usa) | 2018-02-18 |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | Codman & Shurtleff, Inc. | 2017-09-25 |
| K170852 | POD Packing Coil | Penumbra, Inc. | 2017-07-19 |
| 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, G... | Codman & Shurtleff, Inc. | 2017-07-14 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000488192 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488017 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000489137 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000489076 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000489052 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488994 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488932 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488864 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488826 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488796 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488727 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488260 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00763000488239 | Axium™ Detachable Coil System | Micro Therapeutics, Inc. | 2022-10-28 |
| 00847536033368 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-29 |
| 00847536033306 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-29 |
| 00847536032866 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-29 |
| 00847536034310 | Axium PrimeTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536034242 | Axium PrimeTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536030138 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536030077 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536030008 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029996 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029965 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029941 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029910 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029866 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029842 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029781 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029729 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |
| 00847536029668 | AxiumTM | Micro Therapeutics, Inc. | 2019-06-20 |