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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 / K261849

510(k) cleared

VERAFEYE Imaging Catheter (VF-VIC-002)

Luma Vision Limited · Jul 24, 2026 · K261849

FDA cleared the VERAFEYE Imaging Catheter (VF-VIC-002) from Luma Vision Limited on Jul 24, 2026 under K261849, a special 510(k). The device falls under product code OBJ, Catheter, Ultrasound, Intravascular, regulated at 21 CFR 870.1200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 3, 2026. The decision came 51 days later, inside the 90 FDA-day goal for a 510(k).

Luma Vision Limited has one other decision in the tracker over the last 12 months: K260885 (VERAFEYE Imaging and Guidance System (VF-VIS-002)).

Questions & Answers

What did FDA clear under K261849?

K261849 is the FDA 510(k) for VERAFEYE Imaging Catheter (VF-VIC-002), submitted by Luma Vision Limited. FDA's decision date was Jul 24, 2026, under product code OBJ (Catheter, Ultrasound, Intravascular).

Who makes the VERAFEYE Imaging Catheter (VF-VIC-002)?

Luma Vision Limited, based in Dublin, is the applicant of record for K261849.

How long did the K261849 review take?

FDA received the submission on Jun 3, 2026 and issued its decision on Jul 24, 2026, 51 days later.

← All decisions in July 2026

Sources