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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 / August 2026 / K262399

510(k) cleared

Millipede System

Perfuze, Ltd. · Aug 12, 2026 · K262399 · In the directory

FDA cleared the Millipede System from Perfuze, Ltd. on Aug 12, 2026 under K262399, a special 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 Jul 14, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Perfuze, Ltd. has 2 other decisions in the tracker over the last 12 months: K253901 (Millipede88 Access Catheter), K253590 (Millipede System).

Questions & Answers

What did FDA clear under K262399?

K262399 is the FDA 510(k) for Millipede System, submitted by Perfuze, Ltd.. FDA's decision date was Aug 12, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Millipede System?

Perfuze, Ltd., based in Galway, is the applicant of record for K262399. The company is listed in the MedDevice Startups directory.

How long did the K262399 review take?

FDA received the submission on Jul 14, 2026 and issued its decision on Aug 12, 2026, 29 days later.

← All decisions in August 2026

Sources

In the startup directory

Perfuze

Neurology & Neurotech · Galway, Ireland