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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 / K251372

510(k) cleared

VersaD Delivery Catheter

Unity Medical, Inc. · Oct 24, 2025 · K251372

FDA cleared the VersaD Delivery Catheter from Unity Medical, Inc. on Oct 24, 2025 under K251372, a special 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 2, 2025. The decision came 175 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 Unity Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251372?

K251372 is the FDA 510(k) for VersaD Delivery Catheter, submitted by Unity Medical, Inc.. FDA's decision date was Oct 24, 2025, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the VersaD Delivery Catheter?

Unity Medical, Inc., based in Edina, MN, is the applicant of record for K251372.

How long did the K251372 review take?

FDA received the submission on May 2, 2025 and issued its decision on Oct 24, 2025, 175 days later.

← All decisions in October 2025