# K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 14, 2006 after 112 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001901 (2000). 19 ancestors in all.
66 later devices descend from it; 19 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051672: Powerpicc, Bard Access Systems, Inc. (2005) Summary page 1.
- K050310: Bardport Titanium Ports, Bard Access Systems, Inc. (2005) Summary page 2.
- K050600: Miniloc Safety Infusion Set, Specialized Health Products, Intl. (2005) Summary page 2.

## Most influential descendants
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached) (2007), 20 descendants of its own
- K062414: Vortex CT Port Access System and Lifeguard Safety Infusion Set (2007), 20 descendants of its own
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle (2007), 18 descendants of its own
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own
- K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter (2007), 11 descendants of its own

## Recalls of this device
- Aug 8, 2014 · Class II · Z-1272-2015: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of 

## Indications for use
The PowerPort™ Implanted Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the 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 PowerLoc™ Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports. The PowerLoc™ Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with the PowerPort™ device, the PowerLoc™ Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 Ga. and 20 Ga. needles, and 2 ml/s for 22 Ga. needles.

Source page: https://510kreport.com/device/K060812
Methodology: https://510kreport.com/methodology