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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 / K250937

510(k) cleared

Venous Return Cannulae

LivaNova USA, Inc. · Mar 11, 2026 · K250937

FDA cleared the Venous Return Cannulae from LivaNova USA, Inc. on Mar 11, 2026 under K250937, a traditional 510(k). The device falls under product code DWF, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, regulated at 21 CFR 870.4210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 28, 2025. The decision came 348 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

LivaNova USA, Inc. has one other decision in the tracker over the last 12 months: P250013 (aura6000 system).

Questions & Answers

What did FDA clear under K250937?

K250937 is the FDA 510(k) for Venous Return Cannulae, submitted by LivaNova USA, Inc.. FDA's decision date was Mar 11, 2026, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the Venous Return Cannulae?

LivaNova USA, Inc., based in Arvada, CO, is the applicant of record for K250937.

How long did the K250937 review take?

FDA received the submission on Mar 28, 2025 and issued its decision on Mar 11, 2026, 348 days later.

← All decisions in March 2026

Sources