# K222948: Q Distal Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mivi Neuroscience, Inc.
- Decided: Sep 19, 2023 after 357 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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: 2 generations back to K163233 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192558: Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter, Mivi Neurovascular (2020) Summary page 4.

## Indications for use
The Q Distal Access 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/K222948
Methodology: https://510kreport.com/methodology