# K120917: Headway Duo Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Aug 2, 2012 after 128 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960806 (1996). 5 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083343: Headway 17 Microcatheter, MicroVention, Inc. (2008) Summary page 1.

## Most influential descendants
- K131482: Sofia Distal Access Catheter (2013), 11 descendants of its own
- 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

## Indications for use
The Headway Duo Microcatheter is intended for general intravascular use, including the peripheral and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials. The Headway Duo Microcatheter is intended for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the Headway Duo Microcatheter.

Source page: https://510kreport.com/device/K120917
Methodology: https://510kreport.com/methodology