# K141985: True BA V Balloon Valvuloplasty Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 18, 2014 after 58 days
- Product code: OZT (Balloon Aortic Valvuloplasty)
- Device class: 2
- Regulation: 21 CFR 870.1255
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K933483 (1993). 15 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133569: True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM, Bard Peripheral Vascular, Inc. (2013) Summary page 1.
- K131002: Vida PTV Dilataton Catheter, C.R. Bard, Inc. (2013) Summary page 1.

## Most influential descendants
- 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 True™ BAV Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Source page: https://510kreport.com/device/K141985
Methodology: https://510kreport.com/methodology