# K072549: Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 14, 2007 after 65 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 2 (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). 21 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 1.
- K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter, C.R. Bard, Inc. (2007) Summary page 1.

## Most influential descendants
- K251253: PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (2025), 1 descendant of its own
- K252478: Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (2025), 0 descendants of its own
- K232737: PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port (2023), 0 descendants of its own
- K181446: Bard Power-Injectable Implantable Ports (PowerPorts®) (2019), 0 descendants of its own

## Recalls of this device
- Oct 1, 2019 · Class II · Z-1573-2020: 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
- Mar 18, 2010 · Not classified · Z-1525-2010: 8F PowerPort stems were mixed with 6F PowerPorts and packaged.

## 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, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc TM 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 ml/s.

Source page: https://510kreport.com/device/K072549
Methodology: https://510kreport.com/methodology