# K192558: Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mivi Neurovascular
- Decided: Apr 6, 2020 after 202 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 1 generation back to K163233 (2017). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163233: MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter, Mivi Neuroscience, Inc. (2017) Summary page 4.

## Most influential descendants
- K222948: Q Distal Access Catheter (2023), 0 descendants of its own
- K212402: MIVI Q Distal Access Catheter (2021), 0 descendants of its own

## Indications for use
The Q Catheter is indicated for use with compatible guide catheters 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/K192558
Methodology: https://510kreport.com/methodology
