# K182602: SOFIA EX Intracranial Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: May 15, 2019 after 236 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: 6 generations back to K010954 (2001). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131482: Sofia Distal Access Catheter, MicroVention, Inc. (2013) Summary page 4.

## Most influential descendants
- K230775: SOFIA EX Intracranial Support Catheter (2023), 1 descendant of its own
- K254046: BosCATH Support Catheter (2026), 0 descendants of its own

## Indications for use
The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries.

Source page: https://510kreport.com/device/K182602
Methodology: https://510kreport.com/methodology