# K193322: NovaCross CTO Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Nitiloop, Ltd.
- Decided: Apr 2, 2020 after 122 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: 14 generations back to K890505 (1989). 81 ancestors in all.
No later device cites it as a predicate yet.
3 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M, Bridge Medical, Inc. (2011) Summary page 4.
- K171933: ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter, Asahi Intecc Co., Ltd. (2018) Summary page 4.

## Indications for use
The NovaCross CTO Microcatheter is intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond the stenotic lesions, including chronic total occlusions (CTOs), and prior to PTCA or stent intervention. It is also 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/K193322
Methodology: https://510kreport.com/methodology