# K160681: CenterCross Ultra Catheter

- Pathway: 510(k) (Special)
- Applicant: Roxwood Medical, Inc.
- Decided: Jun 17, 2016 after 99 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: 11 generations back to K001992 (2000). 49 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152456: CenterCross Ultra Catheter, Roxwood Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K170403: CenterCross Ultra LV Catheter (2017), 0 descendants of its own

## Indications for use
The CenterCross ULTRA Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

Source page: https://510kreport.com/device/K160681
Methodology: https://510kreport.com/methodology