# K180986: XableCath Support Catheter Product Family

- Pathway: 510(k) (Special)
- Applicant: Xablecath, Inc.
- Decided: May 15, 2018 after 29 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.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170041: XableCath Support Catheter, Xablecath, Inc. (2017) Summary page 4.

## Indications for use
The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices.

Source page: https://510kreport.com/device/K180986
Methodology: https://510kreport.com/methodology