# K033473: Modification to Vortex MP Vascular Access Port

- Pathway: 510(k) (Special)
- Applicant: Horizon Medical Products, Inc.
- Decided: Nov 18, 2003 after 15 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: 2 generations back to K994196 (2000). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032754: Vortex MP, Horizon Medical Products, Inc. (2003)

## Most influential descendants
- 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
- 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

## Recalls of this device
- Sep 20, 2022 · Class II · Z-0132-2023: Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Op
- Aug 30, 2010 · Not classified · Z-3071-2011: The labeling contains errors which result in the products being misbranded

## Indications for use
The Vortex MP Vascular Access System is indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Source page: https://510kreport.com/device/K033473
Methodology: https://510kreport.com/methodology