# K170403: CenterCross Ultra LV Catheter

- Pathway: 510(k) (Special)
- Applicant: Roxwood Medical, Inc.
- Decided: Mar 7, 2017 after 26 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: 12 generations back to K001992 (2000). 50 ancestors in all.
No later device cites it as a predicate yet.
5 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160681: CenterCross Ultra Catheter, Roxwood Medical, Inc. (2016) Summary page 4.

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

Source page: https://510kreport.com/device/K170403
Methodology: https://510kreport.com/methodology