# K083343: Headway 17 Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Dec 4, 2008 after 21 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: 3 generations back to K960806 (1996). 4 ancestors in all.
39 later devices descend from it; 6 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013789: Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189, Boston Scientific, Target (2001) Summary page 1.

## Most influential descendants
- K093160: Headway 21 Microcatheter, Model: MC212150S (2009), 19 descendants of its own
- K120917: Headway Duo Microcatheter (2012), 12 descendants of its own
- K131482: Sofia Distal Access Catheter (2013), 11 descendants of its own
- K110813: Headway 27 Microcatheter (2011), 8 descendants of its own
- K142014: Sofia Distal Access Catheter (2014), 7 descendants of its own

## Indications for use
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

Source page: https://510kreport.com/device/K083343
Methodology: https://510kreport.com/methodology