# K112262: Reflex Ballon Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Reverse Medical Corporation
- Decided: Nov 2, 2011 after 86 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: 2 generations back to K010954 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010954: Concentric Balloon Guide Catheter, Model 90031, Concentric Medical, Inc. (2001) Summary page 1.
- K021899: Concentric Balloon Guide Catheter, Model 90072, Concentric Medical, Inc. (2002) Summary page 1.

## Indications for use
The Reverse Medical ReFle XTm Balloon Guide Catheter is indicated for use in facilitating and guidance of intravascular catheters into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

Source page: https://510kreport.com/device/K112262
Methodology: https://510kreport.com/methodology