K253032 is an FDA 510(k) clearance for the AXS Lift Intracranial Base Catheter. This device is classified as a Catheter, Percutaneous, Neurovasculature (Class II - Special Controls, product code QJP).
Submitted by Stryker Neurovascular (Fremont, 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 FDA review panel. Regulated under 21 CFR 870.1250. To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures.
| 510(k) Number | K253032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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 |