# K193012: speX Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Reflow Medical
- Decided: Feb 19, 2020 after 113 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: 10 generations back to K001992 (2000). 28 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173662: speX Support Catheter, Reflow Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K201811: coraForce and coraFlex Support Catheters (2020), 1 descendant of its own
- K251277: CoraForce Microcatheter, CoraFlex Microcatheter (2025), 0 descendants of its own

## Indications for use
The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary 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/K193012
Methodology: https://510kreport.com/methodology