# K162539: Solitaire 2 Revascularization Device

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Nov 10, 2016 after 59 days
- Product code: POL (Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment)
- Device class: 2
- Regulation: 21 CFR 882.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150049 (2016). 1 ancestor in all.
9 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Concentric Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K181186: Solitare Platinum Revascularization Device (2018), 3 descendants of its own
- K222848: pRESET Thrombectomy Device (2023), 2 descendants of its own
- K181807: Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) (2019), 2 descendants of its own
- K183022: Solitaire 4 Revascularization Device (2019), 2 descendants of its own
- K231539: pRESET LITE Thrombectomy Device (2023), 1 descendant of its own

## Indications for use
1. The Solitaire™ 2 Revascularization Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset. 2. The Solitaire™ Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K162539
Methodology: https://510kreport.com/methodology