# K101542: Headway 17 Advanced Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Aug 6, 2010 after 64 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960806 (1996). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 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.
- K042568: Excelsior 1018 and SL-10 Microcatheters, Boston Scientific Corp (2004) Summary page 1.

## Most influential descendants
- K162565: VIA 17 Microcatheter (2017), 1 descendant of its own
- K254071: p17 XR Microcatheter (2026), 0 descendants of its own
- K192135: VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) (2019), 0 descendants of its own

## Recalls of this device
- Dec 2, 2024 · Class II · Z-0990-2025: Sterility assurance; microcatheter inner packaging may contain incomplete seal.

## Indications for use
The Headway 17 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/K101542
Methodology: https://510kreport.com/methodology