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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 / April 2026 / K253975

510(k) cleared

Radical 6F Access Catheter

Maduro Medical, Inc. · Apr 9, 2026 · K253975

FDA cleared the Radical 6F Access Catheter from Maduro Medical, Inc. on Apr 9, 2026 under K253975, 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 Dec 11, 2025. The decision came 119 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 Maduro Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253975?

K253975 is the FDA 510(k) for Radical 6F Access Catheter, submitted by Maduro Medical, Inc.. FDA's decision date was Apr 9, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Radical 6F Access Catheter?

Maduro Medical, Inc., based in Los Gatos, CA, is the applicant of record for K253975.

How long did the K253975 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Apr 9, 2026, 119 days later.

← All decisions in April 2026