# K153359: BardPort®, SlimPort®, and X-Port® Implanted Ports

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 20, 2016 after 182 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 K873213 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022983: Bardport X-Port Isp Port, C.R. Bard, Inc. (2002) Summary page 4.
- K924250: Plastic Low Profile Subcutaneous Port, Bard Access Systems, Inc. (1993) Summary page 4.
- K880571: Cath-Tech Port Implantable Vascular Access System, Catheter Technology Corp. (1988) Summary page 4.
- K873213: Hickman Plastic Subcutaneous Port, C.R. Bard, Inc. (1987) Summary page 5.
- K870260: Hickman Titanium Subcutaneous Port, C.R. Bard, Inc. (1987) Summary page 5.

## Indications for use
The BardPort®, SlimPort®, and X-Port® 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/K153359
Methodology: https://510kreport.com/methodology