# K072215: Titanium Powerport Isp Implanted Port

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 1, 2007 after 84 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: 8 generations back to K001901 (2000). 21 ancestors in all.
2 later devices descend from it; 2 cite 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)
- 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
- K181446: Bard Power-Injectable Implantable Ports (PowerPorts®) (2019), 0 descendants of its own
- K122834: Polysite Implantable Infusion Ports (2013), 0 descendants of its own

## 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 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/K072215
Methodology: https://510kreport.com/methodology