# K210188: coraCross

- Pathway: 510(k) (Special)
- Applicant: Reflow Medical
- Decided: May 28, 2021 after 123 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). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190393: Wingman 14C Crossing Catheter, Reflow Medical, Inc. (2019) Summary page 4.

## Indications for use
The coraCross Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewire and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic contrast.

Source page: https://510kreport.com/device/K210188
Methodology: https://510kreport.com/methodology