# K150366: SOFIA 6F Catheter

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Mar 27, 2015 after 43 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: 7 generations back to K010954 (2001). 14 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142014: Sofia Distal Access Catheter, MicroVention, Inc. (2014) Summary page 4.
- K131482: Sofia Distal Access Catheter, MicroVention, Inc. (2013) Summary page 4.

## Most influential descendants
- K201682: RIST Radial Access Catheter (2020), 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
- K254178: SAYA 86 Radial Access Guide Catheter (2026), 0 descendants of its own
- K231179: Slinky Catheter (2023), 0 descendants of its own
- K214024: SOFIA 88 Catheter (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K150366
Methodology: https://510kreport.com/methodology