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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 / March 2026 / K253590

510(k) cleared

Millipede System

Perfuze, Ltd. · Mar 16, 2026 · K253590 · In the directory

FDA cleared the Millipede System from Perfuze, Ltd. on Mar 16, 2026 under K253590, a traditional 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 17, 2025. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Perfuze, Ltd. has 2 other decisions in the tracker over the last 12 months: K262399 (Millipede System), K253901 (Millipede88 Access Catheter).

Questions & Answers

What did FDA clear under K253590?

K253590 is the FDA 510(k) for Millipede System, submitted by Perfuze, Ltd.. FDA's decision date was Mar 16, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Millipede System?

Perfuze, Ltd., based in Galway, is the applicant of record for K253590. The company is listed in the MedDevice Startups directory.

How long did the K253590 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 16, 2026, 119 days later.

← All decisions in March 2026

Sources

In the startup directory

Perfuze

Neurology & Neurotech · Galway, Ireland