# K151396: MIVI Mi-AXUS Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mivi Neuroscience, Inc.
- Decided: Dec 9, 2015 after 197 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010954 (2001). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140557: Mivi 6F Guide Catheter, Mivi, LLC (2014) Summary page 4.
- K111380: Neuron Max System, Penumbra, Inc. (2011) Summary page 4.

## Most influential descendants
- K201076: Anchor Dual Lumen Guidewire Catheter (2020), 0 descendants of its own

## Recalls of this device
- Jul 23, 2021 · Class II · Z-2442-2021: There is potential for nonsterility of product due to a possible defect in the pouch seal.
- Jul 23, 2021 · Class II · Z-2441-2021: There is potential for nonsterility of product due to a possible defect in the pouch seal.

## Indications for use
The MIVI Mi-Axus™ Guide Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Source page: https://510kreport.com/device/K151396
Methodology: https://510kreport.com/methodology