# K014117: Modification to Outback Catheter

- Pathway: 510(k) (Special)
- Applicant: Lumend, Inc.
- Decided: Jan 11, 2002 after 28 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001577 (2001). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001577: Outback Catheter, Lumend, Inc. (2001) Summary page 1.

## Most influential descendants
- K032298: Modification to Outback Catheter (2003), 7 descendants of its own
- K040771: Modification to Outback Catheter (2004), 6 descendants of its own
- K043534: Modification to Outback Catheter (2005), 5 descendants of its own
- K083814: Outback LTD RE-Entry Catheter, Model: OTB42120 (2009), 4 descendants of its own
- K150836: OUTBACK Elite Re-Entry Catheter (2015), 2 descendants of its own

## Recalls of this device
- Aug 20, 2008 · Not classified · Z-0279-2009: The Cordis LuMend Outback LTD Re-Entry Catheter - separation rate of the cannula to the deployment slide of the handle assembly is higher than anticipated. The cannula is unable to be retracted into t

## Indications for use
The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K014117
Methodology: https://510kreport.com/methodology