# K181060: Solitaire 2 and Solitaire Platinum Revascularization Device

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurovascular
- Decided: Aug 24, 2018 after 123 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: 10 generations back to K003410 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162539: Solitaire 2 Revascularization Device, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2016) Summary page 4.
- K153071: Solitaire Platinum Revascularization Device, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2015) Summary page 4.
- K160641: Solitaire Platinum Revascularization Device, 6x40 mm, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2017) Summary page 4.
- K161879: Solitaire Platinum Revascularization Device, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2016) Summary page 4.

## Indications for use
1. The Solitaire™ 2 and Solitaire ™ Platinum Revascularization Devices 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™ 2 and Solitaire ™ Platinum Revascularization Devices 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 [V t-PA or who fail [V t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K181060
Methodology: https://510kreport.com/methodology