# K083814: Outback LTD RE-Entry Catheter, Model: OTB42120

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp., A Johnson & Johnson Co.
- Decided: Jan 13, 2009 after 22 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001577 (2001). 5 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K043534: Modification to Outback Catheter, Lumend, Inc. (2005) Summary page 1.

## Most influential descendants
- 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

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

Source page: https://510kreport.com/device/K083814
Methodology: https://510kreport.com/methodology