# K254071: p17 XR Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Wallaby Medical
- Decided: Aug 18, 2026 after 243 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- 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 K960806 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101542: Headway 17 Advanced Microcatheter, MicroVention, Inc. (2010) Summary page 5.

## Indications for use
The p17 XR Microcatheter is indicated for use with compatible accessories in the delivery of interventional and therapeutic devices and infusion of diagnostic agents, such as contrast media, into the peripheral and neuro vasculature. It is not intended for use in coronary vasculature.

Source page: https://510kreport.com/device/K254071
Methodology: https://510kreport.com/methodology