AXS Lift Intracranial Base Catheter— 510(k) K253032
Substantially EquivalentStryker Neurovascular
FDA 510(k) clearance K253032 for AXS Lift Intracranial Base Catheter, Substantially Equivalent on 2026-02-11. Applicant: Stryker Neurovascular. Device class: 2.
Summary
Stryker Neurovascular's AXS Lift Intracranial Base Catheter is filed under product code QJP (Catheter, Percutaneous, Neurovasculature). The record doesn't describe the catheter beyond its name and that code name.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Stryker Neurovascular filed from Fremont, California. Review took 142 calendar days (September 22, 2025 to February 11, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Stryker Neurovascular
- Product code
- Product code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Recent devices under product code QJP
view allMore clearances from Stryker Neurovascular
view all- K261889 — Trevo Trak 21 Microcatheter
- K252694 — Target Detachable Coil
- K251832 — InZone IST Detachment System; IZDS Connecting Cable
- K242289 — Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
- K243593 — AXS Lift Intracranial Base Catheter
Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.