# K113112: Clearway RX NB Catheter

- Pathway: 510(k) (Special)
- Applicant: Atrium Medical Corp.
- Decided: Nov 17, 2011 after 28 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ClearWayTM RX NB is indicated for localized infusion or irrigation of various diagnostic and therapeutic agents into the coronary and peripheral vasculature. It is not indicated for use in the neurovasculature.

Source page: https://510kreport.com/device/K113112
Methodology: https://510kreport.com/methodology