# K113455: Solitaire FR Revascularization Device

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics Dba Ev3 Neurovascular
- Decided: Mar 2, 2012 after 102 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: 5 generations back to K003410 (2001). 11 ancestors in all.
22 later devices descend from it; 5 cite it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062046: Modified Merci Retriever, Model 90050, Concentric Medical, Inc. (2007) Summary page 1.
- K063774: Modification to Merci Retriever, Models X5 and X6, Concentric Medical, Inc. (2007) Summary page 1.
- K070521: Modified Mercy Retriever, Model 90070, Concentric Medical, Inc. (2007) Summary page 1.
- K071172: Modified Merci Retriever, Model 90060, Concentric Medical, Inc. (2007) Summary page 1.
- K081305: Merci Retriever, Concentric Medical, Inc. (2008) Summary page 1.
- K082034: Modification to Merci Retriever, Concentric Medical, Inc. (2008) Summary page 1.
- K090085: Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113, Concentric Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K123378: Solitaire 2 Revascularization Device (2012), 18 descendants of its own
- 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

## Indications for use
The SolitaireTM FR 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/K113455
Methodology: https://510kreport.com/methodology