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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 / September 2025 / K250960

510(k) cleared

DUO Microcatheter

Rev Neuro, LLC · Sep 8, 2025 · K250960

FDA cleared the DUO Microcatheter from Rev Neuro, LLC on Sep 8, 2025 under K250960, 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 Mar 31, 2025. The decision came 161 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Rev Neuro, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250960?

K250960 is the FDA 510(k) for DUO Microcatheter, submitted by Rev Neuro, LLC. FDA's decision date was Sep 8, 2025, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the DUO Microcatheter?

Rev Neuro, LLC, based in Pleasonton, CA, is the applicant of record for K250960.

How long did the K250960 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Sep 8, 2025, 161 days later.

← All decisions in September 2025