# K193596: Wingman 14, Wingman 14C, Wingman 18, Wingman 35

- Pathway: 510(k) (Traditional)
- Applicant: Reflow Medical
- Decided: Feb 20, 2020 after 59 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 K931794 (1994). 59 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120533: Bigboss Catheters Mantatay Catheter Mantaray Guidewires, Bridgepoint Medical (2012) Summary page 4.

## Most influential descendants
- K262013: Kiba CTO Crossing Catheter (2026), 0 descendants of its own

## Indications for use
The Wingman Crossing Catheters (14/14C/18/35) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents. The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents. The Wingman 14, 18, & 35 Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheter is contraindicated for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K193596
Methodology: https://510kreport.com/methodology