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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 / August 2026 / K254211

510(k) cleared

pVasc Net Mechanical Thrombectomy Device

Vesalio, Inc. · Aug 5, 2026 · K254211

FDA cleared the pVasc Net Mechanical Thrombectomy Device from Vesalio, Inc. on Aug 5, 2026 under K254211, a special 510(k). The review panel was Unknown.

FDA logged the submission as received on Dec 29, 2025. The decision came 219 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: K251097 (V-DAC Catheter), K253407 (NeVa PV Thrombectomy Device), K251006 (NeVasc Aspiration System), K251312 (Vesalio Peripheral System).

Questions & Answers

What did FDA clear under K254211?

K254211 is the FDA 510(k) for pVasc Net Mechanical Thrombectomy Device, submitted by Vesalio, Inc.. FDA's decision date was Aug 5, 2026.

Who makes the pVasc Net Mechanical Thrombectomy Device?

Vesalio, Inc., based in San Diego, CA, is the applicant of record for K254211.

How long did the K254211 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Aug 5, 2026, 219 days later.

← All decisions in August 2026

Sources