# K131482: Sofia Distal Access Catheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Nov 22, 2013 after 183 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: 5 generations back to K010954 (2001). 12 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082385: Chaperon Guiding Catheter, MicroVention, Inc. (2008) Summary page 1.
- K120917: Headway Duo Microcatheter, MicroVention, Inc. (2012) Summary page 1.

## Most influential descendants
- K142014: Sofia Distal Access Catheter (2014), 7 descendants of its own
- K150366: SOFIA 6F Catheter (2015), 6 descendants of its own
- K201682: RIST Radial Access Catheter (2020), 2 descendants of its own
- K182602: SOFIA EX Intracranial Support Catheter (2019), 2 descendants of its own
- K241388: Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter (2025), 1 descendant of its own

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

Source page: https://510kreport.com/device/K131482
Methodology: https://510kreport.com/methodology