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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 / K261759

510(k) cleared

Euphora Rapid Exchange (RX) Balloon Dilatation Catheter

Medtronic Ireland · Jul 27, 2026 · K261759

FDA cleared the Euphora Rapid Exchange (RX) Balloon Dilatation Catheter from Medtronic Ireland on Jul 27, 2026 under K261759, 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 May 28, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic Ireland has 3 other decisions in the tracker over the last 12 months: K261428 (NC Euphora Rapid Exchange Balloon Dilatation Catheter), K251970 (Sprinter Legend Rapid Exchange Balloon Dilatation Catheter), K252390 (Telescope Guide Extension Catheter).

Questions & Answers

What did FDA clear under K261759?

K261759 is the FDA 510(k) for Euphora Rapid Exchange (RX) Balloon Dilatation Catheter, submitted by Medtronic Ireland. FDA's decision date was Jul 27, 2026, under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous).

Who makes the Euphora Rapid Exchange (RX) Balloon Dilatation Catheter?

Medtronic Ireland, based in Galway, is the applicant of record for K261759.

How long did the K261759 review take?

FDA received the submission on May 28, 2026 and issued its decision on Jul 27, 2026, 60 days later.

← All decisions in July 2026

Sources