WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K252956

510(k) cleared

Helo Thrombectomy System

Endovascular Engineering, Inc. · Dec 18, 2025 · K252956 · In the directory

FDA cleared the Helo Thrombectomy System from Endovascular Engineering, Inc. on Dec 18, 2025 under K252956, 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 Sep 16, 2025. The decision came 93 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 Endovascular Engineering, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252956?

K252956 is the FDA 510(k) for Helo Thrombectomy System, submitted by Endovascular Engineering, Inc.. FDA's decision date was Dec 18, 2025, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Helo Thrombectomy System?

Endovascular Engineering, Inc., based in Menlo Park, CA, is the applicant of record for K252956. The company is listed in the MedDevice Startups directory.

How long did the K252956 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Dec 18, 2025, 93 days later.

← All decisions in December 2025

Sources

In the startup directory

E2 (Endovascular Engineering)

Cardiovascular · Menlo Park, CA