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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 / K254022

510(k) cleared

FLASH Flex Aorto-Ostial Angioplasty System

Verge Medical, Inc. · Apr 2, 2026 · K254022

FDA cleared the FLASH Flex Aorto-Ostial Angioplasty System from Verge Medical, Inc. on Apr 2, 2026 under K254022, 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 Dec 16, 2025. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Verge Medical, Inc. has one other decision in the tracker over the last 12 months: K253730 (RoVo Mechanical Thrombectomy System).

Questions & Answers

What did FDA clear under K254022?

K254022 is the FDA 510(k) for FLASH Flex Aorto-Ostial Angioplasty System, submitted by Verge Medical, Inc.. FDA's decision date was Apr 2, 2026, under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous).

Who makes the FLASH Flex Aorto-Ostial Angioplasty System?

Verge Medical, Inc., based in Campbell, CA, is the applicant of record for K254022.

How long did the K254022 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Apr 2, 2026, 107 days later.

← All decisions in April 2026

Sources