Cleared Traditional

K243593 - AXS Lift Intracranial Base Catheter

K243593 is the FDA 510(k) clearance for AXS Lift Intracranial Base Catheter by Stryker Neurovascular. It is a Class 2 Neurology device (product code QJP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K243593 · Stryker Neurovascular · Neurology device
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Feb 2025
Decision
90d
Days
Class 2
Risk

K243593 is an FDA 510(k) clearance for the AXS Lift Intracranial Base Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on February 18, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Neurovascular devices

Submission Details

510(k) Number K243593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K243593.
93 NeuFlex Catheter
K251044 · Piraeus Medical · May 2025
PATH BGC
K242392 · Crossroads Neurovascular, Inc. · May 2025
Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
K242289 · Stryker Neurovascular · Mar 2025
VersaD Delivery Catheter
K242051 · Unity Medical, Inc. · Jan 2025
APRO 70 Swift Catheter
K243297 · Alembic, LLC · Jan 2025
Radical the Dude 8F Guide Catheter
K243577 · Maduro Medical, Inc. · Jan 2025