# K211910: Z-6 Atrioseptostomy Catheter

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Jul 19, 2021 after 28 days
- Product code: DXF (Catheter, Septostomy)
- Device class: 2
- Regulation: 21 CFR 870.5175
- 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
Recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

Source page: https://510kreport.com/device/K211910
Methodology: https://510kreport.com/methodology