# K043534: Modification to Outback Catheter

- Pathway: 510(k) (Special)
- Applicant: Lumend, Inc.
- Decided: Jan 21, 2005 after 30 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: 4 generations back to K001577 (2001). 4 ancestors in all.
5 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)
- K040771: Modification to Outback Catheter, Lumend, Inc. (2004) Summary page 1.
- K032298: Modification to Outback Catheter, Lumend, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K221541: LimFlow ARC (2022), 1 descendant of its own
- K251376: LimFlow ARC (2025), 0 descendants of its own
- K131914: Offroad RE-Entry Catheter System (2013), 0 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 guide wires/ 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/K043534
Methodology: https://510kreport.com/methodology