Product code MFE
- Device name
- Agent, Injectable, Embolic
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P030004S043 | Apollo™ Onyx™ Delivery Micro Catheter | Ev3 Neurovascular | 2026-05-26 |
| P030004S040 | Onyx™ Liquid Embolic System (LES) | Ev3 Neurovascular | 2026-04-29 |
| P030004S041 | Apollo™ Onyx™ Delivery Micro Catheter | Ev3 Neurovascular | 2026-04-09 |
| P030004S037 | Apollo™ Onyx™ Delivery Micro Catheter | Ev3 Neurovascular | 2024-12-19 |
| P030004S036 | Apollo™ Onyx™ Delivery Micro Catheter | Ev3 Neurovascular | 2024-11-07 |
| P030004S034 | Apollo™ Onyx™ Delivery Micro Catheter | Ev3 Neurovascular | 2024-09-20 |
| P030004S033 | Onyx™ Liquid Embolic System | Ev3 Neurovascular | 2024-07-26 |
| P030004S031 | Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm | Ev3 Neurovascular | 2024-04-16 |
| P030004S030 | Onyx™ Liquid Embolic System | Ev3 Neurovascular | 2023-11-03 |
| P030004S029 | Apollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm | Ev3 Neurovascular | 2022-07-28 |
| P030004S027 | Onyx™ Liquid Embolic System | Ev3 Neurovascular | 2021-09-16 |
| P030004S028 | Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm | Ev3 Neurovascular | 2021-09-14 |
| P030004S026 | Apollo Onyx Delivery Micro Catheter | Ev3 Neurovascular | 2021-03-18 |
| P030004S025 | Onyx Liquid Embolic System | Ev3 Neurovascular | 2020-11-13 |
| P030004S024 | Apollo Onyx Delivery Micro Catheter | Ev3 Neurovascular | 2020-06-29 |
| P030004S017 | Apollo Onyx Delivery Micro Catheter | Ev3 Neurovascular | 2020-06-15 |
| P030004S023 | Apollo Onyx Delivery Micro Catheter | Ev3 Neurovascular | 2020-02-28 |
| P030004S022 | Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter | Ev3 Neurovascular | 2019-12-19 |
| P030004S021 | Apollo Onyx Delivery Microcatheter | Ev3 Neurovascular | 2019-12-10 |
| P030004S020 | Onyx Liquid Embolic System | Ev3 Neurovascular | 2019-07-24 |
| P030004S019 | Onyx Liquid Embolic System | Ev3 Neurovascular | 2019-06-17 |
| P030004S018 | Onyx Liquid Embolic System | Ev3 Neurovascular | 2019-06-06 |
| P030004S016 | Apollo Onyx Delivery Micro Catheter | Ev3 Neurovascular | 2018-12-27 |
| P030004S015 | Onyx Liquid Embolic System | Ev3 Neurovascular | 2018-06-06 |
| P030004S014 | Onyx Liquid Embolic System | Ev3 Neurovascular | 2018-02-06 |
| P030004S013 | Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight | Ev3 Neurovascular | 2017-10-17 |
| P030004S012 | ONYX LIQUID EMBOLIC SYSTEM | Ev3 Neurovascular | 2017-01-25 |
| P030004S011 | ONYX LIQUID EMBOLIC SYSTEM | Ev3 Neurovascular | 2016-09-20 |
| P030004S010 | ONYX LIQUID EMBOLIC SYSTEM | Ev3 Neurovascular | 2016-03-31 |
| P030004S009 | ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR | Ev3 Neurovascular | 2015-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199150045549 | OnyxTM Liquid Embolic System (LES) | Micro Therapeutics, Inc. | 2026-06-01 |
| 00763000925338 | OnyxTM Liquid Embolic System (LES) | Micro Therapeutics, Inc. | 2026-01-02 |
| 00763000925352 | OnyxTM Liquid Embolic System (LES) | Micro Therapeutics, Inc. | 2026-01-02 |
| 00763000446741 | Apollo | Micro Therapeutics, Inc. | 2022-11-13 |
| 00763000446758 | Apollo | Micro Therapeutics, Inc. | 2022-11-13 |
| 00847536006010 | ApolloTM | Micro Therapeutics, Inc. | 2016-09-26 |
| 00847536006041 | ApolloTM | Micro Therapeutics, Inc. | 2016-09-26 |
| 00836462002463 | Apollo Onyx | Micro Therapeutics, Inc. | 2015-06-08 |
| 00836462002487 | Apollo Onyx | Micro Therapeutics, Inc. | 2015-06-08 |
| 00847536006171 | ONYX 18 | Micro Therapeutics, Inc. | 2015-04-17 |
| 00847536006188 | ONYX 34 | Micro Therapeutics, Inc. | 2015-04-17 |
| 00836462005044 | Onyx 18 | Micro Therapeutics, Inc. | 2014-09-22 |
| 00836462005051 | Onyx 34 | Micro Therapeutics, Inc. | 2014-09-22 |