# K172297: NovaCross Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Nitiloop, Ltd.
- Decided: Oct 18, 2017 after 79 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). 40 ancestors in all.
No later device cites it as a predicate yet.
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.
- K160389: NovaCross Microcatheter, Nitiloop, Ltd. (2016) Summary page 5.

## 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/K172297
Methodology: https://510kreport.com/methodology