# K073423: Mri Powerport Implanted Port with 9.6 FR Silicone Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 19, 2007 after 14 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter, C.R. Bard, Inc. (2007) Summary page 1.
- K873213: Hickman Plastic Subcutaneous Port, C.R. Bard, Inc. (1987) Summary page 1.

## Most influential descendants
- K181446: Bard Power-Injectable Implantable Ports (PowerPorts®) (2019), 0 descendants of its own

## Recalls of this device
- Oct 1, 2019 · Class II · Z-1570-2020: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This ca
- Oct 1, 2019 · Class II · Z-1572-2020: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This ca
- Oct 1, 2019 · Class II · Z-1571-2020: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This ca

## Indications for use
The PowerPortTM implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, IV. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLocTM safety infusion set, the PowerPortTM device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mI/s.

Source page: https://510kreport.com/device/K073423
Methodology: https://510kreport.com/methodology