# K223139: Wallaby 017 Micro Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Wallaby Medical
- Decided: Apr 25, 2023 after 203 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- 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 K945904 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214025: PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter, Medos International SARL (2022) Summary page 4.

## Indications for use
The Wallaby 017 Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic devices such as embolization materials and of diagnostic materials such as contrast media as well as delivery of embolic coils.

Source page: https://510kreport.com/device/K223139
Methodology: https://510kreport.com/methodology