Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
POL is the FDA product code for Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment, a class II device type, regulated under 21 CFR 882.5600. FDA's definition for this code reads: "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...". As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- POL
- Device name
- Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
- FDA 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.
- Regulation
- 21 CFR 882.5600
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 18
- Ingested recalls
- 3
Clearances, product code POL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2018 | 3 |
| 2019 | 4 |
| 2020 | 3 |
| 2021 | 2 |
| 2023 | 3 |
| 2025 | 1 |
Applicants with the most clearances
Product code POL| Applicant | Clearances |
|---|---|
| Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 6 |
| Stryker Corp. | 6 |
| Phenox Inc | 3 |
| Concentric Medical, Inc. | 2 |
| Medtronic Neurovascular | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
