# K193576: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Nov 20, 2020 after 333 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: 12 generations back to K003410 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181186: Solitare Platinum Revascularization Device, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2018) Summary page 4.
- K183022: Solitaire 4 Revascularization Device, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2019) Summary page 4.
- K181807: Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device), Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2019) Summary page 4.

## Indications for use
1. The Solitaire™ 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. 3. The Solitaire™ 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (< 70 cc by CTA or MRA, < 25 cc by MR-DWI). Endovascular therapy with the device should start within 6-16 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Source page: https://510kreport.com/device/K193576
Methodology: https://510kreport.com/methodology