# K001577: Outback Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Lumend, Inc.
- Decided: Jan 11, 2001 after 234 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
No predicates in its family tree.
23 later devices descend from it; 5 cite it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014117: Modification to Outback Catheter (2002), 8 descendants of its own
- K032298: Modification to Outback Catheter (2003), 7 descendants of its own
- K040771: Modification to Outback Catheter (2004), 6 descendants of its own
- K101479: Wingman Extendable Tip Support Catheter (2010), 5 descendants of its own
- K043534: Modification to Outback Catheter (2005), 5 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

Source page: https://510kreport.com/device/K001577
Methodology: https://510kreport.com/methodology