# K161879: Solitaire Platinum Revascularization Device

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Sep 21, 2016 after 75 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003410 (2001). 15 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153071: Solitaire Platinum Revascularization Device, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2015) Summary page 4.

## Most influential descendants
- K181186: Solitare Platinum Revascularization Device (2018), 3 descendants of its own
- K183022: Solitaire 4 Revascularization Device (2019), 2 descendants of its own
- K203358: Solitaire X Revascularization Device (2021), 0 descendants of its own
- K193576: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) (2020), 0 descendants of its own
- K181060: Solitaire 2 and Solitaire Platinum Revascularization Device (2018), 0 descendants of its own

## Indications for use
The Solitaire™ Platinum Revascularization Device is intended 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K161879
Methodology: https://510kreport.com/methodology