# K210431: ReCross

- Pathway: 510(k) (Traditional)
- Applicant: Imds Operations B.V.
- Decided: Jul 15, 2021 after 153 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: 8 generations back to K010579 (2001). 23 ancestors in all.
No later device cites it as a predicate yet.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200324: NHancer Rx, Imds Operations B.V. (2020) Summary page 4.

## Indications for use
The ReCross Dual Lumen guide wire support catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.

Source page: https://510kreport.com/device/K210431
Methodology: https://510kreport.com/methodology