# K123378: Solitaire 2 Revascularization Device

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics Dba Ev3 Neurovascular
- Decided: Nov 30, 2012 after 29 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: 6 generations back to K003410 (2001). 12 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113455: Solitaire FR Revascularization Device, Micro Therapeutics Dba Ev3 Neurovascular (2012) Summary page 1.

## Most influential descendants
- K141491: Solitaire 2 Revascularization Device (2014), 17 descendants of its own
- K153071: Solitaire Platinum Revascularization Device (2015), 10 descendants of its own
- K160641: Solitaire Platinum Revascularization Device, 6x40 mm (2017), 8 descendants of its own
- K203592: Tigertriever and Tigertriever 17 Revascularization Devce (2021), 5 descendants of its own
- K161879: Solitaire Platinum Revascularization Device (2016), 5 descendants of its own

## Indications for use
The SolitaireTM 2 Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemnic 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/K123378
Methodology: https://510kreport.com/methodology