# K131914: Offroad RE-Entry Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 31, 2013 after 127 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.
No later device cites it as a predicate yet.
0 of 7 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 1.

## Indications for use
The OffRoad Re-Entry Catheter System is intended to facilitate the placement and positioning of guidewires within the peripheral vasculature beyond stenotic lesions, including sub and chronic total occlusions.

Source page: https://510kreport.com/device/K131914
Methodology: https://510kreport.com/methodology