# K133569: True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM

- Pathway: 510(k) (Special)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Dec 20, 2013 after 30 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: 1 generation back to K121083 (2012). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121083: True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20MM X 4.5CM, True Dilatation Percutaneous Translumina, Loma Vista Medical (2012) Summary page 1.

## Most influential descendants
- K142083: True Flow Valvuloplasty Perfusion Catheter (2015), 3 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
- K152613: True Flow Valvuloplasty Perfusion Catheter (2016), 2 descendants of its own
- K241040: Amethyst HP PTA OTW 0.035 Catheter (2024), 1 descendant of its own

## Indications for use
The True Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

Source page: https://510kreport.com/device/K133569
Methodology: https://510kreport.com/methodology