# K141649: Spex Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Reflow Medical
- Decided: Nov 5, 2014 after 138 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 K001992 (2000). 26 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112035: Valet Micro Catheter, Volcano Corporation (2012) Summary page 4.
- K072750: Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066, Spectranetics Corp. (2007) Summary page 4.
- K082337: Minnie Support Catheter, Vascular Solutions, Inc. (2009) Summary page 4.

## Most influential descendants
- K173662: speX Support Catheter (2017), 5 descendants of its own
- K193012: speX Support Catheter (2020), 2 descendants of its own
- K201811: coraForce and coraFlex Support Catheters (2020), 1 descendant of its own
- K200094: speX LP Support Catheter (2020), 1 descendant of its own
- K251277: CoraForce Microcatheter, CoraFlex Microcatheter (2025), 0 descendants of its own

## Indications for use
The speX 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/K141649
Methodology: https://510kreport.com/methodology