# K081680: Nucleus-X, Model 230X

- Pathway: 510(k) (Special)
- Applicant: NuMED, Inc.
- Decided: Jul 10, 2008 after 23 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: 1 generation back to K022722 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022722: Pta and PTV, NuMED, Inc. (2002) Summary page 1.

## Indications for use
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. • A patient with isolated pulmonary stenosis A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not requrie surgical intervention.

Source page: https://510kreport.com/device/K081680
Methodology: https://510kreport.com/methodology