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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 / K261428

510(k) cleared

NC Euphora Rapid Exchange Balloon Dilatation Catheter

Medtronic Ireland · Aug 14, 2026 · K261428

FDA cleared the NC Euphora Rapid Exchange Balloon Dilatation Catheter from Medtronic Ireland on Aug 14, 2026 under K261428, a traditional 510(k). The device falls under product code LOX, Catheters, Transluminal Coronary Angioplasty, Percutaneous, regulated at 21 CFR 870.5100 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 30, 2026. The decision came 106 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Ireland has 3 other decisions in the tracker over the last 12 months: K261759 (Euphora Rapid Exchange (RX) Balloon Dilatation Catheter), K251970 (Sprinter Legend Rapid Exchange Balloon Dilatation Catheter), K252390 (Telescope Guide Extension Catheter).

Questions & Answers

What did FDA clear under K261428?

K261428 is the FDA 510(k) for NC Euphora Rapid Exchange Balloon Dilatation Catheter, submitted by Medtronic Ireland. FDA's decision date was Aug 14, 2026, under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous).

Who makes the NC Euphora Rapid Exchange Balloon Dilatation Catheter?

Medtronic Ireland, based in Galway, is the applicant of record for K261428.

How long did the K261428 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Aug 14, 2026, 106 days later.

← All decisions in August 2026

Sources