# K214107: XO CROSS CORONARY Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Transit Scientific, LLC
- Decided: Apr 11, 2022 after 103 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: 7 generations back to K935425 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 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.

## Indications for use
The XO Cross Coronary is a support catheter intended to guide and support a guidewire during access of the peripheral or coronary vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Source page: https://510kreport.com/device/K214107
Methodology: https://510kreport.com/methodology