# K130923: 5F Dignity CT Titanium Port

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Jul 31, 2013 after 119 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 5F Dignity® Midsize CT Titanium Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, WV.fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media. For power injection of contrast media. the maximum recommended infusion rate is 5 mI/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 mI/s with a 22 gauge non-coring power injectable needle.

Source page: https://510kreport.com/device/K130923
Methodology: https://510kreport.com/methodology