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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 / October 2025 / K252390

510(k) cleared

Telescope Guide Extension Catheter

Medtronic, Ireland · Oct 29, 2025 · K252390

FDA cleared the Telescope Guide Extension Catheter from Medtronic, Ireland on Oct 29, 2025 under K252390, a traditional 510(k). The device falls under product code DQY, Catheter, Percutaneous, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 31, 2025. The decision came 90 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), K261759 (Euphora Rapid Exchange (RX) Balloon Dilatation Catheter), K251970 (Sprinter Legend Rapid Exchange Balloon Dilatation Catheter).

Questions & Answers

What did FDA clear under K252390?

K252390 is the FDA 510(k) for Telescope Guide Extension Catheter, submitted by Medtronic, Ireland. FDA's decision date was Oct 29, 2025, under product code DQY (Catheter, Percutaneous).

Who makes the Telescope Guide Extension Catheter?

Medtronic, Ireland, based in Galway, is the applicant of record for K252390.

How long did the K252390 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Oct 29, 2025, 90 days later.

← All decisions in October 2025

Sources