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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 / August 2026 / K261523

510(k) cleared

Vertex Thrombectomy System

Jupiter Endovascular · Aug 4, 2026 · K261523 · In the directory

FDA cleared the Vertex Thrombectomy System from Jupiter Endovascular on Aug 4, 2026 under K261523, a traditional 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 7, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Jupiter Endovascular has one other decision in the tracker over the last 12 months: K252027 (Vertex(TM) Catheter).

Questions & Answers

What did FDA clear under K261523?

K261523 is the FDA 510(k) for Vertex Thrombectomy System, submitted by Jupiter Endovascular. FDA's decision date was Aug 4, 2026, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Vertex Thrombectomy System?

Jupiter Endovascular, based in Menlo Park, CA, is the applicant of record for K261523. The company is listed in the MedDevice Startups directory.

How long did the K261523 review take?

FDA received the submission on May 7, 2026 and issued its decision on Aug 4, 2026, 89 days later.

← All decisions in August 2026

Sources

In the startup directory

Jupiter Endovascular

Cardiovascular · Menlo Park, CA

Vertex Thrombectomy System

OUR COVERAGE

Questions & Answers

What did FDA clear under K261523?

Who makes the Vertex Thrombectomy System?

How long did the K261523 review take?

Vertex Thrombectomy System

Who makes the Vertex Thrombectomy System?