# K153238: Dignity Dual Port

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp ( Medical Components)
- Decided: Mar 15, 2016 after 127 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 K090512 (2009). 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)
- K090512: Powerport Duo M.R.I. Implanted Port with 9.5 FR. Dual Lumen Chronoflex Polyurethane Catheter, C.R. Bard, Inc. (2009) Summary page 4.

## Indications for use
The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port can be used for infusion of medications, 1.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of biood samples. When used with a power injectable needle, the Dignity® Dual Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

Source page: https://510kreport.com/device/K153238
Methodology: https://510kreport.com/methodology