# K122367: Bard PTV Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 2, 2012 after 88 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: 5 generations back to K933483 (1993). 10 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102473: Mullins-X PTV Catheter, NuMED, Inc. (2010) Summary page 1.
- K120971: Atlas Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2012) Summary page 1.

## Most influential descendants
- 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
- K251915: Amethyst HP PTA OTW 0.035 Catheter (2025), 0 descendants of its own

## Indications for use
The Bard PTV Dilatation Catheters are 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.

Source page: https://510kreport.com/device/K122367
Methodology: https://510kreport.com/methodology