# K993245: Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom

- Pathway: 510(k) (Special)
- Applicant: Alba Critical Care, Ltd.
- Decided: Oct 28, 1999 after 30 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925444 (1993). 1 ancestor in all.
1 later device descends 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)
- K925444: Cardiac Output Pulmonary Artery Catheter & Monitor, Ami-Med Corp. (1993) Summary page 1.

## Most influential descendants
- K081776: Continuous Cardiac Ouput Monitor, Truccom (2008), 0 descendants of its own

## Indications for use
The Continuous Cardiac Output Pulmonary Artery Catheter and Continuous Cardiac Output Monitor system’s intended use is for the assessment of a patient’s haemodynamic condition through direct intracardiac (right heart) and pulmonary artery pressure monitoring, cardiac output determination and for infusing solutions. The distal port on the catheter also allows for sampling of venous blood.

Source page: https://510kreport.com/device/K993245
Methodology: https://510kreport.com/methodology