# K133335: Powerport Implantable Port

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 14, 2014 after 108 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). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081311: Powerport Implanted Port with Groshong Catheter, C.R. Bard, Inc. (2008) Summary page 1.
- K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter, C.R. Bard, Inc. (2007) Summary page 1.
- K050310: Bardport Titanium Ports, Bard Access Systems, Inc. (2005) Summary page 2.
- K032044: X-Prot Duo Port, C.R. Bard, Inc. (2003) Summary page 2.
- K022983: Bardport X-Port Isp Port, C.R. Bard, Inc. (2002) Summary page 2.
- K924250: Plastic Low Profile Subcutaneous Port, Bard Access Systems, Inc. (1993) Summary page 2.
- K912702: Plastic Attachable Dual Port, Davol, Inc. (1991) Summary page 2.
- K880571: Cath-Tech Port Implantable Vascular Access System, Catheter Technology Corp. (1988) Summary page 3.
- K873213: Hickman Plastic Subcutaneous Port, C.R. Bard, Inc. (1987) Summary page 3.

## Indications for use
The PowerPort® Implantable Port is 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. When used with a PowerLoc safety infusion set, the PowerPort device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s. The BardPort, SlimPort, and X-Port implantable 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/K133335
Methodology: https://510kreport.com/methodology