# K201811: coraForce and coraFlex Support Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Reflow Medical, Inc.
- Decided: Oct 26, 2020 after 117 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: 11 generations back to K001992 (2000). 29 ancestors in all.
1 later device descends 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)
- K193012: speX Support Catheter, Reflow Medical (2020) Summary page 4.

## Most influential descendants
- K251277: CoraForce Microcatheter, CoraFlex Microcatheter (2025), 0 descendants of its own

## Indications for use
Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.

Source page: https://510kreport.com/device/K201811
Methodology: https://510kreport.com/methodology