# K150667: True Dilatation Balloon Valvuloplasty Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 17, 2015 after 93 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: 2 generations back to K121083 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 4.

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

Source page: https://510kreport.com/device/K150667
Methodology: https://510kreport.com/methodology