FDA product code POL: 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. It is a Class II device, regulated under 21 CFR 882.5600 and reviewed by the Neurology panel. FDA has cleared 17 510(k) submissions under POL, 4 in the last five years, from 6 different applicants. The average 510(k) review took 134 days (median 121); 175 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for POL devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Device class | Class II |
| Regulation | 21 CFR 882.5600 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for POL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 137 |
| 2019 | 4 | 130 |
| 2020 | 3 | 136 |
| 2021 | 2 | 146 |
| 2023 | 3 | 139 |
| 2025 | 1 | 175 |
Compare with all 510(k) review times · Search every POL clearance
Top POL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 6 | 2021-03-01 |
| Phenox Limited | 3 | 2025-02-28 |
| Stryker Neurovascular | 3 | 2023-03-29 |
| Stryker | 3 | 2020-02-07 |
| Medtronic Neurovascular | 1 | 2018-08-24 |
1 more applicants have POL clearances. See the full list in Caduvo.
Most recent POL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242676 | Phenox Limited | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | 2025-02-28 | 175 |
| K231539 | Phenox Limited | pRESET LITE Thrombectomy Device | 2023-10-21 | 144 |
| K223305 | Stryker Neurovascular | Trevo NXT ProVue Retriever | 2023-03-29 | 153 |
| K222848 | Phenox Limited | pRESET Thrombectomy Device | 2023-01-20 | 121 |
| K210502 | Stryker Neurovascular | Trevo NXT ProVue Retriever | 2021-08-27 | 186 |
Recalls for POL devices
3 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-04-23.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code POL?
POL is the FDA product code for neurovascular mechanical thrombectomy device for acute ischemic stroke treatment. It is a Class II device, regulated under 21 CFR 882.5600 and reviewed by the Neurology panel.
What device class is POL?
Class II, regulation 21 CFR 882.5600. Typical premarket route: 510(k).
How long does a 510(k) take for product code POL?
Across 17 cleared submissions the average was 134 days from receipt to decision (median 121).
Which companies have the most POL clearances?
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (6); Phenox Limited (3); Stryker Neurovascular (3); Stryker (3); Medtronic Neurovascular (1).
Have POL devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2024-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code POL
- Run a recall and safety report across every POL manufacturer
- Watch product code POL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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