# K262013: Kiba CTO Crossing Catheter

- Pathway: 510(k) (Special)
- Applicant: Reflow Medical, Inc.
- Decided: Aug 28, 2026 after 74 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- 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: 12 generations back to K931794 (1994). 60 ancestors in all.
No later device cites it as a predicate yet.
3 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193596: Wingman 14, Wingman 14C, Wingman 18, Wingman 35, Reflow Medical (2020) Summary page 5.

## Indications for use
The Kiba CTO Crossing Catheter is intended to be used in conjuction 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 placment of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents. The Kiba CTO Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature.

Source page: https://510kreport.com/device/K262013
Methodology: https://510kreport.com/methodology