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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 / January 2026 / K251970

510(k) cleared

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Medtronic, Ireland · Jan 17, 2026 · K251970

FDA cleared the Sprinter Legend Rapid Exchange Balloon Dilatation Catheter from Medtronic, Ireland on Jan 17, 2026 under K251970, 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 Jun 26, 2025. The decision came 205 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: K261428 (NC Euphora Rapid Exchange Balloon Dilatation Catheter), K261759 (Euphora Rapid Exchange (RX) Balloon Dilatation Catheter), K252390 (Telescope Guide Extension Catheter).

Questions & Answers

What did FDA clear under K251970?

K251970 is the FDA 510(k) for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter, submitted by Medtronic, Ireland. FDA's decision date was Jan 17, 2026, under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous).

Who makes the Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

Medtronic, Ireland, based in Galway, is the applicant of record for K251970.

How long did the K251970 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on Jan 17, 2026, 205 days later.

← All decisions in January 2026

Sources