# K160389: NovaCross Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Nitiloop, Ltd.
- Decided: Mar 11, 2016 after 29 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: 10 generations back to K001992 (2000). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143608: NovaCross Microcatheter, Nitiloop, Ltd. (2015) Summary page 5.

## Most influential descendants
- K172297: NovaCross Microcatheter (2017), 0 descendants of its own

## Indications for use
The NovaCross™ Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

Source page: https://510kreport.com/device/K160389
Methodology: https://510kreport.com/methodology