510(k) K251253

PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port by Bard Access Systems, Inc. — Product Code LJT

K251253 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port". The FDA issued a decision of Substantially Equivalent on June 18, 2025. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.