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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 / K253901

510(k) cleared

Millipede88 Access Catheter

Perfuze, Ltd. · Jul 9, 2026 · K253901 · In the directory

FDA cleared the Millipede88 Access Catheter from Perfuze, Ltd. on Jul 9, 2026 under K253901, 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 Dec 5, 2025. The decision came 216 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), K253590 (Millipede System).

Questions & Answers

What did FDA clear under K253901?

K253901 is the FDA 510(k) for Millipede88 Access Catheter, submitted by Perfuze, Ltd.. FDA's decision date was Jul 9, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Millipede88 Access Catheter?

Perfuze, Ltd., based in Galway, is the applicant of record for K253901. The company is listed in the MedDevice Startups directory.

How long did the K253901 review take?

FDA received the submission on Dec 5, 2025 and issued its decision on Jul 9, 2026, 216 days later.

← All decisions in July 2026

Sources

In the startup directory

Perfuze

Neurology & Neurotech · Galway, Ireland