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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 / K253106

510(k) cleared

AngioVac Cannula

AngioDynamics, Inc. · Oct 24, 2025 · K253106

FDA cleared the AngioVac Cannula from AngioDynamics, Inc. on Oct 24, 2025 under K253106, a special 510(k). The device falls under product code DWF, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, regulated at 21 CFR 870.4210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 24, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

AngioDynamics, Inc. has 2 other decisions in the tracker over the last 12 months: K253198 (NanoKnife Generator (H78720300351US0)), K252509 (AlphaVac Multipurpose Mechanical Aspiration System F1885).

Questions & Answers

What did FDA clear under K253106?

K253106 is the FDA 510(k) for AngioVac Cannula, submitted by AngioDynamics, Inc.. FDA's decision date was Oct 24, 2025, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the AngioVac Cannula?

AngioDynamics, Inc., based in Queensburgy, NY, is the applicant of record for K253106.

How long did the K253106 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Oct 24, 2025, 30 days later.

← All decisions in October 2025

Sources