# K150514: Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 20, 2015 after 266 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: 1 generation back to K122899 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122899: Powerport Clearvue Slim Implantable Port, C.R. Bard, Inc. (2012) Summary page 4.

## Indications for use
The PowerPort® implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc® safety infusion set, the PowerPort® device 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/K150514
Methodology: https://510kreport.com/methodology