# K081933: Avalon Elite Multi-Port Venous Femoral Catheter, 20FR, 22FR, 24FR, 26FR, 28FR

- Pathway: 510(k) (Traditional)
- Applicant: Avalon Laboratories, LLC
- Decided: Oct 3, 2008 after 88 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 K884129 (1988). 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)
- K052524: Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit, Medtronic Perfusion Systems (2005) Summary page 2.

## Indications for use
The Avalon EliteTM Multi-Port Venous Femoral Catheter with Introducer is indicated to drain central venous blood via the femoral vein during extracorporeal procedures for up to six hours.

Source page: https://510kreport.com/device/K081933
Methodology: https://510kreport.com/methodology