# K034065: Modification to X-Port Duo Port

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 15, 2004 after 17 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: 2 generations back to K912702 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032044: X-Prot Duo Port, C.R. Bard, Inc. (2003) Summary page 1.

## Indications for use
The BardPort®, SlimPortTM and X-PortTM Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

Source page: https://510kreport.com/device/K034065
Methodology: https://510kreport.com/methodology