# K062414: Vortex CT Port Access System and Lifeguard Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Rita Medical Systems, Inc.
- Decided: Feb 1, 2007 after 168 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 23 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 1.
- K010767: Lifeport VTX Access System,Model VTX 7000 Series, Horizon Medical Products, Inc. (2001) Summary page 2.
- K013871: Lifeguard Safety Infusion Set, Horizon Medical Products, Inc. (2002) Summary page 2.

## Most influential descendants
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (2017), 6 descendants of its own
- K072375: Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set (2007), 5 descendants of its own
- K081472: Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports (2008), 4 descendants of its own
- K102385: Norfolk Medical Norport Family of Ports (2011), 3 descendants of its own

## Recalls of this device
- Feb 22, 2021 · Class II · Z-1466-2021: AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the speci
- Aug 1, 2011 · Not classified · Z-0056-2012: The product may contain an incorrect size catheter and introducer.

## Indications for use
The Vortex™ CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood. When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19Ga sizes, the Vortex™ CT Port Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec. The LifeGuard Safety Infusion Set is an administration set with a non-coring right angle needle and manually activated needle-stick prevention safety mechanism. This device is used to access surgically implanted vascular ports. The LifeGuard 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 Vortex™ CT Port Access System, the LifeGuard Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, only models LG-19-75, LG-19-100, LG-20-75, LG-20-100, and LG-20-150 may be used at a maximum infusion rate of 5ml/sec.

Source page: https://510kreport.com/device/K062414
Methodology: https://510kreport.com/methodology