Cleared Traditional

AXS Lift Intracranial Base Catheter

K243593 · Stryker Neurovascular · Neurology

Feb 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K243593 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 18, 2025, 90 days after receiving the submission on November 20, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K243593 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2024
Decision Date	February 18, 2025
Days to Decision	90 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