# K173661: Wingman 35 Crossing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Reflow Medical, Inc.
- Decided: Apr 18, 2018 after 140 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). 22 ancestors in all.
No later device cites it as a predicate yet.
2 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141547: Wingman Extendable Tip Support Catheter, Reflow Medical (2014) Summary page 4.

## Indications for use
The Wingman 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

Source page: https://510kreport.com/device/K173661
Methodology: https://510kreport.com/methodology