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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 / October 2025 / K251312

510(k) cleared

Vesalio Peripheral System

Vesalio, Inc. · Oct 24, 2025 · K251312

FDA cleared the Vesalio Peripheral System from Vesalio, Inc. on Oct 24, 2025 under K251312, a traditional 510(k). The device falls under product code QEZ, Aspiration Thrombectomy Catheter, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 28, 2025. The decision came 179 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), K251006 (NeVasc Aspiration System).

Questions & Answers

What did FDA clear under K251312?

K251312 is the FDA 510(k) for Vesalio Peripheral System, submitted by Vesalio, Inc.. FDA's decision date was Oct 24, 2025, under product code QEZ (Aspiration Thrombectomy Catheter).

Who makes the Vesalio Peripheral System?

Vesalio, Inc., based in San Diego, CA, is the applicant of record for K251312.

How long did the K251312 review take?

FDA received the submission on Apr 28, 2025 and issued its decision on Oct 24, 2025, 179 days later.

← All decisions in October 2025

Sources