# K252478: Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port

- Pathway: 510(k) (Special)
- Applicant: Bard Access Systems, Inc.
- Decided: Sep 5, 2025 after 29 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251253: PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port, Bard Access Systems, Inc. (2025) Summary page 5.
- K090512: Powerport Duo M.R.I. Implanted Port with 9.5 FR. Dual Lumen Chronoflex Polyurethane Catheter, C.R. Bard, Inc. (2009) Summary page 5.

## Indications for use
The Bard Power-Injectable Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLoc™ Safety Infusion Set, the Bard Power-Injectable Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

Source page: https://510kreport.com/device/K252478
Methodology: https://510kreport.com/methodology