510(k) clearance

p17 XR Microcatheter

FDA 510(k) source

510(k) number

K254071

Applicant

Wallaby Medical

Decision date

Aug 18, 2026

Date received

Dec 18, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QJP

Device type

Catheter, Percutaneous, Neurovasculature

Device class

Class II

Regulation

21 CFR 870.1250

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Laguna Hills, CA, US