# 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

- Pathway: 510(k) (Traditional)
- Applicant: Mivi Neuroscience, Inc.
- Decided: Apr 6, 2017 after 140 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K180201: Route 92 Medical Access System (2018), 9 descendants of its own
- K200121: Route 92 Medical 088 Access System, 110 cm (2020), 8 descendants of its own
- K201518: Route 92 Medical 088 Access System (2020), 5 descendants of its own
- K210635: Route 92 Medical Full Length 088 Access System (2021), 3 descendants of its own
- K222743: Route 92 Medical Full Length 070 Access System (2022), 2 descendants of its own

## Indications for use
The MIVI Mi-EXT 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/K163233
Methodology: https://510kreport.com/methodology