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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 / January 2026 / K251097

510(k) cleared

V-DAC Catheter

Vesalio, Inc. · Jan 6, 2026 · K251097

FDA cleared the V-DAC Catheter from Vesalio, Inc. on Jan 6, 2026 under K251097, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 10, 2025. The decision came 271 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), K253407 (NeVa PV Thrombectomy Device), K251006 (NeVasc Aspiration System), K251312 (Vesalio Peripheral System).

Questions & Answers

What did FDA clear under K251097?

K251097 is the FDA 510(k) for V-DAC Catheter, submitted by Vesalio, Inc.. FDA's decision date was Jan 6, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the V-DAC Catheter?

Vesalio, Inc., based in San Diego, CA, is the applicant of record for K251097.

How long did the K251097 review take?

FDA received the submission on Apr 10, 2025 and issued its decision on Jan 6, 2026, 271 days later.

← All decisions in January 2026

Sources