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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 / November 2025 / K251006

510(k) cleared

NeVasc Aspiration System

Vesalio, Inc. · Nov 10, 2025 · K251006

FDA cleared the NeVasc Aspiration System from Vesalio, Inc. on Nov 10, 2025 under K251006, a traditional 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 1, 2025. The decision came 223 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Vesalio, Inc. has 4 other decisions in the tracker over the last 12 months: K254211 (pVasc Net Mechanical Thrombectomy Device), K251097 (V-DAC Catheter), K253407 (NeVa PV Thrombectomy Device), K251312 (Vesalio Peripheral System).

Questions & Answers

What did FDA clear under K251006?

K251006 is the FDA 510(k) for NeVasc Aspiration System, submitted by Vesalio, Inc.. FDA's decision date was Nov 10, 2025, under product code NRY (Catheter, Thrombus Retriever).

Who makes the NeVasc Aspiration System?

Vesalio, Inc., based in San Diego, CA, is the applicant of record for K251006.

How long did the K251006 review take?

FDA received the submission on Apr 1, 2025 and issued its decision on Nov 10, 2025, 223 days later.

← All decisions in November 2025

Sources