# K150836: OUTBACK Elite Re-Entry Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Corporation, A Johnson & Johnson Co.
- Decided: Apr 29, 2015 after 30 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: 6 generations back to K001577 (2001). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083814: Outback LTD RE-Entry Catheter, Model: OTB42120, Cordis Corp., A Johnson & Johnson Co. (2009) Summary page 4.

## Most influential descendants
- K221541: LimFlow ARC (2022), 1 descendant of its own
- K251376: LimFlow ARC (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K150836
Methodology: https://510kreport.com/methodology