Definition: A Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Is A Prescription Device Used In The Treatment Of Acute Ischemic Stroke To Improve Clinical Outcomes. The Device Is Delivered Into The Neurovasculature With An Endovas
| Device Type ID | 3790 |
| Device Name | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Physical State | The Device Is Delivered Into The Neurovasculature With An Endovascular Approach And Mechanically Removes Thrombus From The Body And Restores Blood Flow. |
| Technical Method | The Device Is Delivered Into The Neurovasculature With An Endovascular Approach And Mechanically Removes Thrombus From The Body And Restores Blood Flow. |
| Target Area | Neurovasculature |
| Regulation Description | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5600 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3790 |
| Device | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Product Code | POL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment. |
| CFR Regulation Number | 882.5600 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CONCENTRIC MEDICAL, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
STRYKER CORP. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |