# K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR

- Pathway: 510(k) (Traditional)
- Applicant: Avalon Laboratories, LLC
- Decided: Oct 6, 2008 after 101 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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 K003288 (2001). 1 ancestor in all.
19 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003288: Origen Dual Lumen Catheter, Origen Biomedical, Inc. (2001) Summary page 2.

## Most influential descendants
- K142673: Bio-Medicus Adult Cannulae and Introducer (2014), 9 descendants of its own
- K140999: Tandemheart Veno-Venous Cannula (2014), 7 descendants of its own
- K180453: Bio-Medicus Adult Cannulae and Introducer (2018), 6 descendants of its own
- K160257: PROTEK Duo 31 Fr. Veno-Venous Cannula Set (2016), 5 descendants of its own
- K171610: MC3 QuickFlow Dual Lumen Catheter (2017), 3 descendants of its own

## Indications for use
The Avalon EliteTM Bi-Caval Dual Lumen Catheter is indicated for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.

Source page: https://510kreport.com/device/K081820
Methodology: https://510kreport.com/methodology