# K150187: ELITECROSS Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corporation, A Johnson & Johnson Company
- Decided: May 19, 2015 after 112 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: 3 generations back to K021593 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140438: Micro Guide Catheter Elite, Cordis Corp., A Johnson & Johnson Co. (2014) Summary page 4.

## Indications for use
The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

Source page: https://510kreport.com/device/K150187
Methodology: https://510kreport.com/methodology