| Device |
neurovascular mechanical thrombectomy device for acute ischemic stroke treatment |
| Regulation Description |
Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment. |
| 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 endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature. |
| 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 Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | POL |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.5600
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
