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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K253032

510(k) cleared

AXS Lift Intracranial Base Catheter

Stryker Neurovascular · Feb 11, 2026 · K253032

FDA cleared the AXS Lift Intracranial Base Catheter from Stryker Neurovascular on Feb 11, 2026 under K253032, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 22, 2025. The decision came 142 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Neurovascular has 3 other decisions in the tracker over the last 12 months: K261889 (Trevo Trak 21 Microcatheter), K252694 (Target Detachable Coil), K251832 (InZone IST Detachment System; IZDS Connecting Cable).

Questions & Answers

What did FDA clear under K253032?

K253032 is the FDA 510(k) for AXS Lift Intracranial Base Catheter, submitted by Stryker Neurovascular. FDA's decision date was Feb 11, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the AXS Lift Intracranial Base Catheter?

Stryker Neurovascular, based in Fremont, CA, is the applicant of record for K253032.

How long did the K253032 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Feb 11, 2026, 142 days later.

← All decisions in February 2026

Sources