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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 / K251207

510(k) cleared

Sangria Thrombectomy System

Avantec Vascular Corporation · Jan 7, 2026 · K251207

FDA cleared the Sangria Thrombectomy System from Avantec Vascular Corporation on Jan 7, 2026 under K251207, a traditional 510(k). The device falls under product code QEW, Peripheral 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 Apr 18, 2025. The decision came 264 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Avantec Vascular Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251207?

K251207 is the FDA 510(k) for Sangria Thrombectomy System, submitted by Avantec Vascular Corporation. FDA's decision date was Jan 7, 2026, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Sangria Thrombectomy System?

Avantec Vascular Corporation, based in Sunnyvale, CA, is the applicant of record for K251207.

How long did the K251207 review take?

FDA received the submission on Apr 18, 2025 and issued its decision on Jan 7, 2026, 264 days later.

← All decisions in January 2026