# K033250: Edwards Lifesciences Vantex Central Venous Catheters with Thermistor

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 30, 2003 after 84 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Edwards Lifesciences Vantex Central Venous Catheters with Oligon material: named in the summary without a submission number
- (no number) Edwards Lifesciences Swan-Ganz True-Size Thermodilution Catheters: named in the summary without a submission number

## Most influential descendants
- K061250: Multicath Expert (2006), 1 descendant of its own
- K072702: Stryker Antimic Catheter (2008), 0 descendants of its own

## Indications for use
The Edwards Lifesciences Vantex Central Venous Catheters with Thermistor are indicated for use in patients requiring administration of solutions, blood sampling, temperature monitoring, and central venous pressure monitoring.

Source page: https://510kreport.com/device/K033250
Methodology: https://510kreport.com/methodology