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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 / K260188

510(k) cleared

LimFlow Vector

LimFlow, Inc. · Mar 18, 2026 · K260188

FDA cleared the LimFlow Vector from LimFlow, Inc. on Mar 18, 2026 under K260188, a special 510(k). The device falls under product code MGZ, Valvulotome, regulated at 21 CFR 870.4885 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 22, 2026. The decision came 55 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for LimFlow, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260188?

K260188 is the FDA 510(k) for LimFlow Vector, submitted by LimFlow, Inc.. FDA's decision date was Mar 18, 2026, under product code MGZ (Valvulotome).

Who makes the LimFlow Vector?

LimFlow, Inc., based in Irvine, CA, is the applicant of record for K260188.

How long did the K260188 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on Mar 18, 2026, 55 days later.

← All decisions in March 2026