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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 / K253407

510(k) cleared

NeVa PV Thrombectomy Device

Vesalio, Inc. · Nov 24, 2025 · K253407

FDA cleared the NeVa PV Thrombectomy Device from Vesalio, Inc. on Nov 24, 2025 under K253407, a traditional 510(k). The device falls under product code QEX, Coronary 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 30, 2025. The decision came 55 days later, inside the 90 FDA-day goal for a 510(k).

Vesalio, Inc. has 4 other decisions in the tracker over the last 12 months: K254211 (pVasc Net Mechanical Thrombectomy Device), K251097 (V-DAC Catheter), K251006 (NeVasc Aspiration System), K251312 (Vesalio Peripheral System).

Questions & Answers

What did FDA clear under K253407?

K253407 is the FDA 510(k) for NeVa PV Thrombectomy Device, submitted by Vesalio, Inc.. FDA's decision date was Nov 24, 2025, under product code QEX (Coronary Mechanical Thrombectomy With Aspiration).

Who makes the NeVa PV Thrombectomy Device?

Vesalio, Inc., based in San Diego, CA, is the applicant of record for K253407.

How long did the K253407 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Nov 24, 2025, 55 days later.

← All decisions in November 2025

Sources