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

About This 510(k) Submission

K252478 is an FDA 510(k) clearance for the Vaccess? CT Low-Profile Power-Injectable Implantable Port; Vaccess? CT Power-Injectable Implantable Port; PowerPort? duo M.R.I. ? Implantable Port, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on September 5, 2025, 29 days after receiving the submission on August 7, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.