# POL: Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

- Device class: 2; regulation: 21 CFR 882.5600; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 149 days (middle half 127–170)
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 2
- 2018: 3
- 2019: 4
- 2020: 3
- 2021: 2
- 2023: 3
- 2025: 1

## Most-cited predicates
- K162539: Solitaire 2 Revascularization Device (2016), cited by 4
- K222848: pRESET Thrombectomy Device (2023), cited by 2
- DEN150049: Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm (2016), cited by 2
- K190779: Trevo XP ProVue Retriever (2019), cited by 2
- K181807: Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) (2019), cited by 2
- K181186: Solitare Platinum Revascularization Device (2018), cited by 2
- K183022: Solitaire 4 Revascularization Device (2019), cited by 2
- K200117: Trevo NXT ProVue Retriever (2020), cited by 1
- K192207: Trevo NXT ProVue Retriever (2019), cited by 1
- K173352: Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) (2018), cited by 1

Source page: https://510kreport.com/product-code/POL
Data by year (CSV): https://510kreport.com/product-code/POL.csv