# K032557: Triumph VTX with Lifevalve Catheter

- Pathway: 510(k) (Special)
- Applicant: Horizon Medical Products, Inc.
- Decided: Sep 9, 2003 after 21 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: 1 generation back to K933986 (1994). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933986: HMP Polysulfone Port, Horizon Medical Products, Inc. (1994) Summary page 1.
- K951814: Triumph-1 Port, Horizon Medical Products, Inc. (1995) Summary page 1.
- K010189: Vortex Access System, Horizon Medical Products, Inc. (2001)

## Most influential descendants
- 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
- K061424: Celsite/ Celsite Concept, Access Ports (2006), 1 descendant of its own

## Recalls of this device
- Sep 27, 2010 · Not classified · Z-0403-2011: Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

## Indications for use
The TriumphThfVTX@Port with Lifevalve Catheter is a totally implantable vascular access system intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products. The TriumphTMVTX@Port with Lifevalve@Catheter is also indicated for the withdrawal of blood samples.

Source page: https://510kreport.com/device/K032557
Methodology: https://510kreport.com/methodology