AXS Lift Intracranial Base Catheter
by Stryker Neurovascular 2 variants
510(k) K243593
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243593 | Date18 Feb 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QJP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The AXS Lift Intracranial Base Catheter is a percutaneous neurovascular catheter designed for intracranial vascular access. It is intended to facilitate the delivery of interventional therapies by providing a stable platform for catheterization within the neurovascular system, combining features of both biaxial and triaxial systems for enhanced procedural support.
This device is supplied as a single-use, sterile product and is intended for use in neurovascular interventional procedures. It is classified as a Class II medical device under FDA regulations (870.1250) and has received FDA 510(k) clearance (K243593). The catheter is intended for use in MRI-safe environments, though specific MRI compatibility details should be confirmed with the manufacturer. Storage and handling instructions are provided in the accompanying documentation.
From the manufacturer
AXS Lift is the first of its kind intracranial base catheter designed to give you the simplicity of a biaxial setup with the support of a triaxial system.
Stryker announced the launch of its AXS Lift Intracranial Base Catheter, a novel device developed to simplify neurovascular access and enhance delivery of interventional therapies.