# K141491: Solitaire 2 Revascularization Device

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Oct 22, 2014 after 139 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: 7 generations back to K003410 (2001). 13 ancestors in all.
17 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)
- K123378: Solitaire 2 Revascularization Device, Micro Therapeutics Dba Ev3 Neurovascular (2012) Summary page 4.
- K113455: Solitaire FR Revascularization Device, Micro Therapeutics Dba Ev3 Neurovascular (2012) Summary page 4.

## Most influential descendants
- 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
- K181186: Solitare Platinum Revascularization Device (2018), 3 descendants of its own

## Indications for use
The Solitaire™ 2 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 (IVt-PA) or fail IVt-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K141491
Methodology: https://510kreport.com/methodology