# K251277: CoraForce Microcatheter, CoraFlex Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Reflow Medical, Inc.
- Decided: Aug 22, 2025 after 120 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: 12 generations back to K001992 (2000). 30 ancestors in all.
No later device cites it as a predicate yet.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201811: coraForce and coraFlex Support Catheters, Reflow Medical, Inc. (2020) Summary page 5.

## Indications for use
The Cora Microcatheters 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 the delivery of saline solutions of diagnostic contrast.

Source page: https://510kreport.com/device/K251277
Methodology: https://510kreport.com/methodology