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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 / July 2026 / K261889

510(k) cleared

Trevo Trak 21 Microcatheter

Stryker Neurovascular · Jul 1, 2026 · K261889

FDA cleared the Trevo Trak 21 Microcatheter from Stryker Neurovascular on Jul 1, 2026 under K261889, a special 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 Jun 5, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

Stryker Neurovascular has 3 other decisions in the tracker over the last 12 months: K253032 (AXS Lift Intracranial Base Catheter), K252694 (Target Detachable Coil), K251832 (InZone IST Detachment System; IZDS Connecting Cable).

Questions & Answers

What did FDA clear under K261889?

K261889 is the FDA 510(k) for Trevo Trak 21 Microcatheter, submitted by Stryker Neurovascular. FDA's decision date was Jul 1, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Trevo Trak 21 Microcatheter?

Stryker Neurovascular, based in Fremont, CA, is the applicant of record for K261889.

How long did the K261889 review take?

FDA received the submission on Jun 5, 2026 and issued its decision on Jul 1, 2026, 26 days later.

← All decisions in July 2026

Sources