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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 / April 2026 / K253589

510(k) cleared

Liberant RX Aspiration Catheter

Medtronic Interventional Vascular, Inc. · Apr 23, 2026 · K253589

FDA cleared the Liberant RX Aspiration Catheter from Medtronic Interventional Vascular, Inc. on Apr 23, 2026 under K253589, a traditional 510(k). The device falls under product code QEZ, Aspiration Thrombectomy Catheter, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 17, 2025. The decision came 157 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Medtronic Interventional Vascular, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253589?

K253589 is the FDA 510(k) for Liberant RX Aspiration Catheter, submitted by Medtronic Interventional Vascular, Inc.. FDA's decision date was Apr 23, 2026, under product code QEZ (Aspiration Thrombectomy Catheter).

Who makes the Liberant RX Aspiration Catheter?

Medtronic Interventional Vascular, Inc., based in Danvers, MA, is the applicant of record for K253589.

How long did the K253589 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Apr 23, 2026, 157 days later.

← All decisions in April 2026