# K231044: R2P Navicross

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corporation
- Decided: Jul 27, 2023 after 106 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 K935425 (1994). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110540: Terumo Support Catheter, Terumo Medical Corp. (2011) Summary page 6.

## Most influential descendants
- K253361: Teleport Glide Microcatheter (2026), 0 descendants of its own

## Indications for use
R2P NaviCross is indicated to guide and support a guidewire during access of the peripheral vasculature through an access site, including but not limited to the radial artery, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.

Source page: https://510kreport.com/device/K231044
Methodology: https://510kreport.com/methodology