POL — Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment Class II
Classification Details
- Product Code
- POL
- Device Class
- Class II
- Regulation Number
- 882.5600
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242676 | phenox limited | pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device | February 28, 2025 |
| K231539 | phenox limited | pRESET LITE Thrombectomy Device | October 21, 2023 |
| K223305 | stryker neurovascular | Trevo NXT ProVue Retriever | March 29, 2023 |
| K222848 | phenox limited | pRESET Thrombectomy Device | January 20, 2023 |
| K210502 | stryker neurovascular | Trevo NXT ProVue Retriever | August 27, 2021 |
| K203358 | micro therapeutics, inc. d/b/a ev3 neurovascular | Solitaire X Revascularization Device | March 1, 2021 |
| K203219 | stryker neurovascular | Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever | December 29, 2020 |
| K193576 | micro therapeutics, inc. d/b/a ev3 neurovascular | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Devic | November 20, 2020 |
| K200117 | stryker | Trevo NXT ProVue Retriever | February 7, 2020 |
| K192207 | stryker | Trevo NXT ProVue Retriever | November 22, 2019 |
| K190779 | stryker | Trevo XP ProVue Retriever | June 25, 2019 |
| K181807 | micro therapeutics, inc. d/b/a ev3 neurovascular | Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Devic | March 6, 2019 |
| K183022 | micro therapeutics, inc. d/b/a ev3 neurovascular | Solitaire 4 Revascularization Device | January 29, 2019 |
| K181186 | micro therapeutics, inc. d/b/a ev3 neurovascular | Solitare Platinum Revascularization Device | October 25, 2018 |
| K181060 | medtronic neurovascular | Solitaire 2 and Solitaire Platinum Revascularization Device | August 24, 2018 |
| K173352 | concentric medical | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | February 15, 2018 |
| K162539 | micro therapeutics, inc. d/b/a ev3 neurovascular | Solitaire 2 Revascularization Device | November 10, 2016 |
| DEN150049 | concentric medical | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProV | September 2, 2016 |