# K200094: speX LP Support Catheter

- Pathway: 510(k) (Special)
- Applicant: Reflow Medical
- Decided: Mar 18, 2020 after 62 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.
1 later device descends from it; 1 cites it directly.
1 of 30 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
- K233350: SINC Support Catheter (2024), 0 descendants of its own

## Indications for use
The speX LP Support 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/K200094
Methodology: https://510kreport.com/methodology