# K102473: Mullins-X PTV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: NuMED, Inc.
- Decided: Dec 9, 2010 after 101 days
- Product code: OMZ (Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter)
- 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.
6 later devices descend from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- K122367: Bard PTV Dilatation Catheter (2012), 5 descendants of its own
- K131002: Vida PTV Dilataton Catheter (2013), 4 descendants of its own
- K141985: True BA V Balloon Valvuloplasty Catheter (2014), 3 descendants of its own
- K212588: Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter (2022), 2 descendants of its own
- K241040: Amethyst HP PTA OTW 0.035 Catheter (2024), 1 descendant of its own

## Indications for use
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 require surgical intervention. This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Source page: https://510kreport.com/device/K102473
Methodology: https://510kreport.com/methodology