# K130639: Elite-I (BI) Dual Lumen Catheter; Elite-I (RA) Dual Lumen Catheter; Elite-I (Bix)Dual Lumen Catheter

- Pathway: 510(k) (Special)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: May 16, 2013 after 66 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: 2 generations back to K003288 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR, Avalon Laboratories, LLC (2008) Summary page 1.

## Indications for use
The ELITE-i 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/K130639
Methodology: https://510kreport.com/methodology