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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 / November 2025 / K252509

510(k) cleared

AlphaVac Multipurpose Mechanical Aspiration System F1885

AngioDynamics, Inc. · Nov 24, 2025 · K252509

FDA cleared the AlphaVac Multipurpose Mechanical Aspiration System F1885 from AngioDynamics, Inc. on Nov 24, 2025 under K252509, a traditional 510(k). The device falls under product code QEZ, Aspiration Thrombectomy Catheter, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 8, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

AngioDynamics, Inc. has 2 other decisions in the tracker over the last 12 months: K253198 (NanoKnife Generator (H78720300351US0)), K253106 (AngioVac Cannula).

Questions & Answers

What did FDA clear under K252509?

K252509 is the FDA 510(k) for AlphaVac Multipurpose Mechanical Aspiration System F1885, submitted by AngioDynamics, Inc.. FDA's decision date was Nov 24, 2025, under product code QEZ (Aspiration Thrombectomy Catheter).

Who makes the AlphaVac Multipurpose Mechanical Aspiration System F1885?

AngioDynamics, Inc., based in Queensburgy, NY, is the applicant of record for K252509.

How long did the K252509 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Nov 24, 2025, 108 days later.

← All decisions in November 2025

Sources