Cleared Traditional

AXS Lift Intracranial Base Catheter

K253032 · Stryker Neurovascular · Neurology
Feb 2026
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K253032 is an FDA 510(k) clearance for the AXS Lift Intracranial Base Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on February 11, 2026, 142 days after receiving the submission on September 22, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K253032 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2025
Decision Date February 11, 2026
Days to Decision 142 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QJP — Catheter, Percutaneous, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures