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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 / K260606

510(k) cleared

Echo Large Bore Introducer Sheath

Echo Medical, LLC · Apr 29, 2026 · K260606

FDA cleared the Echo Large Bore Introducer Sheath from Echo Medical, LLC on Apr 29, 2026 under K260606, a traditional 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 24, 2026. The decision came 64 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Echo Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260606?

K260606 is the FDA 510(k) for Echo Large Bore Introducer Sheath, submitted by Echo Medical, LLC. FDA's decision date was Apr 29, 2026, under product code DYB (Introducer, Catheter).

Who makes the Echo Large Bore Introducer Sheath?

Echo Medical, LLC, based in Irvine, CA, is the applicant of record for K260606.

How long did the K260606 review take?

FDA received the submission on Feb 24, 2026 and issued its decision on Apr 29, 2026, 64 days later.

← All decisions in April 2026