# K211594: Trevo Trak 21 Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Stryker Neurovascular
- Decided: Nov 26, 2021 after 186 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003086 (2001). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192122: Trevo Trak 21 Microcatheter, Stryker (2019) Summary page 4.

## Most influential descendants
- K261889: Trevo Trak 21 Microcatheter (2026), 0 descendants of its own
- K250960: DUO Microcatheter (2025), 0 descendants of its own

## Recalls of this device
- Aug 30, 2024 · Class II · Z-0021-2025: Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneo
- Apr 23, 2024 · Class II · Z-1906-2024: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc
- Dec 6, 2023 · Class II · Z-1085-2024: The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

## Indications for use
The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

Source page: https://510kreport.com/device/K211594
Methodology: https://510kreport.com/methodology