# K141516: Mindframe Capture LP Revascularization Device

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Feb 5, 2015 after 241 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- 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.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has 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 4.

## Recalls of this device
- Feb 26, 2018 · Class I · Z-1701-2018: There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.

## Indications for use
The Capture™ LP 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/K141516
Methodology: https://510kreport.com/methodology