# K180889: Tractus Crossing Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Tractus Vascular, LLC
- Decided: Dec 7, 2018 after 247 days
- Product code: DQY (Catheter, Percutaneous)
- 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: 8 generations back to K935425 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092396: Spectranetics Quick Cross Extreme Support Catheters, Spectranetics Corp. (2009) Summary page 4.
- K133539: Total Across, Medtronic Vascular (2014) Summary page 4.
- K132701: Primi Support Catheter, Thermopeutix, Inc. (2013) Summary page 4.

## Indications for use
The Tractus CSC is intended to be used during interventional procedures in the coronary and peripheral vasculatures to support a guidewire and facilitate access in discrete regions, allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media.

Source page: https://510kreport.com/device/K180889
Methodology: https://510kreport.com/methodology