# K081472: Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Sep 23, 2008 after 119 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: 9 generations back to K001901 (2000). 34 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072375: Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set, AngioDynamics, Inc. (2007) Summary page 1.
- K062414: Vortex CT Port Access System and Lifeguard Safety Infusion Set, Rita Medical Systems, Inc. (2007) Summary page 1.
- K905841: Strato Port Introducer KT (12 FR) LPS 5200/Modified, Strato Medical Corp. (1991) Summary page 1.
- K953529: Strato/Infusaid Life & Infuse-a-Port Implantable Port System, Strato/Infusaid, Inc. (1996) Summary page 1.
- K010189: Vortex Access System, Horizon Medical Products, Inc. (2001)
- K032557: Triumph VTX with Lifevalve Catheter, Horizon Medical Products, Inc. (2003) Summary page 1.

## Most influential descendants
- K102385: Norfolk Medical Norport Family of Ports (2011), 3 descendants of its own
- K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set (2011), 2 descendants of its own
- K112713: Norfolk Medical-Sportport-Family of Ports (2011), 1 descendant of its own
- K192291: TidalPort-AP Implantable Apheresis Vascular Access Port (2020), 0 descendants of its own

## Recalls of this device
- Jul 16, 2009 · Not classified · Z-1898-2009: The product may contain an incorrect size catheter and introducer.

## Indications for use
The SmartPort CT Series Port Access System is indicated for any patient requiring repeated access of the vascular system for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood. The SmartPort CT Series Port Access System is also indicated for power injection of contrast media at a maximum infusion rate of 3 ml/sec or 5 ml/sec when used with 20 Ga or 19 Ga power injectable infusion sets.

Source page: https://510kreport.com/device/K081472
Methodology: https://510kreport.com/methodology