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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 / April 2026 / K252445

510(k) cleared

Fusion Bioline Vascular Graft

Maquet Cardiovascular, LLC · Apr 27, 2026 · K252445

FDA cleared the Fusion Bioline Vascular Graft from Maquet Cardiovascular, LLC on Apr 27, 2026 under K252445, a traditional 510(k). The device falls under product code DSY, Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, regulated at 21 CFR 870.3450 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 4, 2025. The decision came 266 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 Maquet Cardiovascular, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252445?

K252445 is the FDA 510(k) for Fusion Bioline Vascular Graft, submitted by Maquet Cardiovascular, LLC. FDA's decision date was Apr 27, 2026, under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter).

Who makes the Fusion Bioline Vascular Graft?

Maquet Cardiovascular, LLC, based in Wayne, NJ, is the applicant of record for K252445.

How long did the K252445 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Apr 27, 2026, 266 days later.

← All decisions in April 2026