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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 / K252277

510(k) cleared

Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)

Vascular Flow Technologies Limited · Oct 20, 2025 · K252277

FDA cleared the Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) from Vascular Flow Technologies Limited on Oct 20, 2025 under K252277, 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 Jul 22, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Vascular Flow Technologies Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252277?

K252277 is the FDA 510(k) for Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645), submitted by Vascular Flow Technologies Limited. FDA's decision date was Oct 20, 2025, under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter).

Who makes the Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)?

Vascular Flow Technologies Limited, based in Dundee, is the applicant of record for K252277.

How long did the K252277 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Oct 20, 2025, 90 days later.

← All decisions in October 2025