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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 / September 2025 / K252478

510(k) cleared

Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port

Bard Access Systems, Inc. · Sep 5, 2025 · K252478

FDA cleared the Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port from Bard Access Systems, Inc. on Sep 5, 2025 under K252478, a special 510(k). The device falls under product code LJT, Port & Catheter, Implanted, Subcutaneous, Intravascular, regulated at 21 CFR 880.5965 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Aug 7, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Bard Access Systems, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252478?

K252478 is the FDA 510(k) for Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port, submitted by Bard Access Systems, Inc.. FDA's decision date was Sep 5, 2025, under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular).

Who makes the Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port?

Bard Access Systems, Inc., based in Salt Lake Ciy,, UT, is the applicant of record for K252478.

How long did the K252478 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Sep 5, 2025, 29 days later.

← All decisions in September 2025